Neisseria Meningitidis, Haemophilus Influenzae Type b
Conditions
Keywords
Conjugate, Immunogenicity, Hib-MenCY-TT vaccine, Haemophilus type b, Safety, Reactogenicity
Brief summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in infants and toddlers.
Interventions
BIOLOGICALHib-MenCY-TT (MenHibrix®)
4 doses administered intramuscularly (IM) in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 in the HibCY Group.
BIOLOGICALPediarix®
3 doses administered IM in the left upper anterolateral thigh at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper anterolateral thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper anterolateral thigh at Month 4 in the PedHIB Group.
BIOLOGICALRotarix®
2 doses administered orally at Day 0 and Month 2 each in the HibCY Group and PedHIB Group.
BIOLOGICALPrevnar 13®
4 doses administered IM in the left lower anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 each in the HibCY Group and PedHIB Group.
BIOLOGICALPedvaxHIB®
3 doses administered IM in the right upper anterolateral thigh at Day 0, Month 2 and Month 10-13 in the PedHIB Group.
BIOLOGICALHavrix®
2 doses administered IM in the left upper anterolateral thigh at Month 10-13 and Month 16-19 each in the HibCY Group and PedHIB Group.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born full-term (i.e. born after a gestation period of at least 37 weeks inclusive). * 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.
Exclusion criteria
* Child in care. * 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 of immunosuppressants or other immune-modifying drugs since birth prior to the first vaccine dose. Inhaled and topical steroids are allowed. * Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, rotavirus, pneumococcus, hepatitis A and/or poliovirus; more than one previous dose of hepatitis B vaccine. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccines. Subjects may receive inactivated influenza vaccine or pandemic influenza vaccines any time during the study according to the national recommendation. Measles, mumps, rubella and varicella vaccination are allowed 30 days before or 30 days after the final vaccination of Hib-MenCY-TT or PedvaxHIB. * History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B, hepatitis A, rotavirus, and/or poliovirus 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 vaccines, including dry natural latex rubber. Hypersensitivity to any component of the vaccines, including gelatin or neomycin. * Major congenital defects or serious chronic illnesses. * History of any neurologic disorders or seizures. A single, simple febrile seizure is allowed. * Subjects with history of intussusceptions or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusceptions. * Acute disease and/or fever at the time of enrollment. * Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL | 1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14] | Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch. |
| Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs). | 2 months post-dose 2 of Rotarix (Month 4) | Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch |
| Anti-Streptococcus (S) Pneumoniae GMCs | 1 month post-dose 3 of Prevnar 13 (Month 5) | Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch. |
| Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL | 1 month post-dose 2 of Havrix (Month 17-20) | Percentage of subjects with Anti-Havrix (Anti-HAV) antibody concentrations was assessed. The cut-off value is ≥15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch |
| Anti-S. Pneumoniae GMCs | 1 month post-dose 4 of Prevnar 13 (Month 11-14) | Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL | 2 month post-dose 2 of Rotarix (Month 4) | The cut-off value is 20 Units (U)/mL Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups. |
| Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL | 1 month post-dose 1 of Havrix (Month 11-14) | The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups. |
| Anti-HAV GMCs ≥ 15 mIU/mL | 1 month post-dose 1 of HAV (M11-14). | The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups |
| GMCs for Anti-HAV Antibodies ≥15mIU/mL. | 1 month post-dose 2 of HAV (Month 17-20). | The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups |
| Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL. | 2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Months 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)] | The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups. |
| Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | 4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose | Solicited local adverse events include pain, redness and swelling at injection site. |
| Percentage of Subjects Reporting Any Solicited General AEs. | 4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose. | Solicited general AEs include fever \[defined as temperature ≥38.0 degrees Celsius (°C) by any method\], drowsiness, irritability/fussiness and loss of appetite. |
| Percentage of Subjects Reporting Any Unsolicited AEs. | During 31 days (Day 0 to Day 30) after all vaccines post-primary (Dose 1-3) and post-fourth dose (Dose 4) | Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited adverse event. |
| Percentage of Subjects Reporting Any Serious Adverse Events (SAEs). | During the entire study period (from Day 0 to Month 17-20) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14) | The cut-off values are 0.15, 0.26, 0.35 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups |
| Anti-PRP GMCs≥ 0.15 µg/mL. | 2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Month 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)] | Anti-PRP antibody concentrations were assessed by Enzyme-Linked-Immunosorbent-Assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in micrograms per mililiter (µg/mL).The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups. |
| Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL | 2 months post-dose 2 [PedHib group only (Month 4)] and 1 month postdose 3 [HibCY group only (Month 5)]. | The cut-off value for this assay was 1.0 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups. |
| Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14). | The cut off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups. |
| Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY | 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14). | The cut-off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups. |
Countries
United States
Participant flow
Recruitment details
600 subjects were recruited from 27 centers in the United States. The study consists of 2 epochs: Epoch 001: starting at Day 0 and ending at the day preceding the 4th vaccination (Month 10-13) and Epoch 002: starting at Month 10-13 and ending at Month 17-20, 31 days after the 2nd Havrix vaccination
Pre-assignment details
All enrolled subjects were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| HibCY Group Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19. | 297 |
| PedHIB Group Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19. | 303 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 5 |
| Overall Study | Child was in care of grandmother | 0 | 1 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Loss of kaiser coverage | 4 | 10 |
| Overall Study | Lost kaiser health plan unable to contac | 1 | 0 |
| Overall Study | Lost to Follow-up | 11 | 15 |
| Overall Study | Migrated/moved from study area | 11 | 13 |
| Overall Study | Mother lost custody of child | 0 | 1 |
| Overall Study | N/A for vaccine administration | 0 | 1 |
| Overall Study | Protocol Violation | 8 | 2 |
| Overall Study | Withdrawal by Subject | 29 | 25 |
Baseline characteristics
| Characteristic | HibCY Group | PedHIB Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 297 Participants | 303 Participants | 600 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.6 Weeks STANDARD_DEVIATION 1.1 | 8.6 Weeks STANDARD_DEVIATION 1.1 | 8.6 Weeks STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized African Heritage / African American | 29 Participants | 19 Participants | 48 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 11 Participants | 12 Participants | 23 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 9 Participants | 8 Participants | 17 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized Unspecified | 36 Participants | 32 Participants | 68 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 201 Participants | 218 Participants | 419 Participants |
| Sex: Female, Male Female | 148 Participants | 140 Participants | 288 Participants |
| Sex: Female, Male Male | 149 Participants | 163 Participants | 312 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 297 | 0 / 303 |
| other Total, other adverse events | 282 / 297 | 291 / 303 |
| serious Total, serious adverse events | 8 / 297 | 11 / 303 |
Outcome results
Primary
Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs).
Anti-rotavirus serum IgA was assessed by ELISA, tabulated as GMCs and expressed in Units per mililiter (U/mL).Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per a hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch
Time frame: 2 months post-dose 2 of Rotarix (Month 4)
Population: The analysis was performed on the Rota ATP cohort for analysis of immunogenicity, which included all evaluable subjects who received the two doses of Rotarix vaccine and for whom immunogenicity results were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HibCY Group | Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs). | 138.9 U/mL |
| PedHIB Group | Anti-rotavirus Serum Immunoglobulin A (IgA) Geometric Mean Concentrations (GMCs). | 115.0 U/mL |
Comparison: GMC ratios between HibCY and PedHIB groups for anti-Rota IgA concentrations 2 months after the second dose of Rotarix vaccine97.5% CI: [0.77, 1.9]ANCOVA
Primary
Anti-S. Pneumoniae GMCs
Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch
Time frame: 1 month post-dose 4 of Prevnar 13 (Month 11-14)
Population: The analysis was performed on the Forth dose ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received four doses of Prevnar 13 vaccine and for whom immunogenicity results were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-4 antibody | 1.36 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-9V antibody | 1.38 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-6A antibody | 6.80 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-14 antibody | 7.14 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-3 antibody | 0.52 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-18C antibody | 1.62 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-6B antibody | 5.57 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-19A antibody | 5.47 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-5 antibody | 2.36 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-19F antibody | 6.23 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-7F antibody | 4.16 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-23F antibody | 3.28 µg/mL |
| HibCY Group | Anti-S. Pneumoniae GMCs | Anti-1 antibody | 2.00 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-23F antibody | 2.68 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-1 antibody | 1.60 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-3 antibody | 0.51 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-4 antibody | 1.24 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-5 antibody | 2.23 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-6A antibody | 5.63 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-6B antibody | 4.94 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-7F antibody | 3.81 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-9V antibody | 1.24 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-14 antibody | 6.13 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-18C antibody | 1.42 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-19A antibody | 5.03 µg/mL |
| PedHIB Group | Anti-S. Pneumoniae GMCs | Anti-19F antibody | 5.54 µg/mL |
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the fourth dose97.5% CI: [1.04, 1.51]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the fourth dose97.5% CI: [0.83, 1.24]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the fourth dose97.5% CI: [0.92, 1.31]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the fourth dose97.5% CI: [0.87, 1.28]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the fourth dose97.5% CI: [1.01, 1.44]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the fourth dose97.5% CI: [0.94, 1.36]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the fourth dose97.5% CI: [0.93, 1.29]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the fourth dose97.5% CI: [0.94, 1.33]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the fourth dose97.5% CI: [0.96, 1.41]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the fourth dose97.5% CI: [0.97, 1.35]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the fourth dose97.5% CI: [0.9, 1.31]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the fourth dose97.5% CI: [0.95, 1.34]ANCOVA
Comparison: GMC ratios between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the fourth dose97.5% CI: [1, 1.5]ANCOVA
Primary
Anti-Streptococcus (S) Pneumoniae GMCs
Antibody concentrations against S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F were assessed by ELISA, tabulated as GMCs and expressed in µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.
Time frame: 1 month post-dose 3 of Prevnar 13 (Month 5)
Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity, which included all evaluable subjects who have received three doses of Prevnar 13 vaccine and for whom immunogenicity results were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-7F antibody | 2.59 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-9V antibody | 0.78 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-5 antibody | 0.80 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-14 antibody | 4.77 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-1 antibody | 1.49 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-18C antibody | 0.91 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-6A antibody | 1.76 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-19A antibody | 1.31 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-4 antibody | 0.81 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-19F antibody | 2.25 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-6B antibody | 1.00 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-23F antibody | 0.94 µg/mL |
| HibCY Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-3 antibody | 0.55 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-23F antibody | 0.80 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-1 antibody | 1.26 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-3 antibody | 0.48 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-4 antibody | 0.74 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-5 antibody | 0.68 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-6A antibody | 1.37 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-6B antibody | 0.87 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-9V antibody | 0.63 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-14 antibody | 4.16 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-18C antibody | 0.74 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-19A antibody | 1.13 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-19F antibody | 2.10 µg/mL |
| PedHIB Group | Anti-Streptococcus (S) Pneumoniae GMCs | Anti-7F antibody | 2.36 µg/mL |
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 1 concentrations one month after the third dose.97.5% CI: [0.95, 1.47]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 3 concentrations one month after the third dose.97.5% CI: [0.93, 1.42]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 4 concentrations one month after the third dose.97.5% CI: [0.9, 1.31]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 5 concentrations one month after the third dose.97.5% CI: [0.95, 1.47]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6A concentrations one month after the third dose.97.5% CI: [1.03, 1.63]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 6B concentrations one month after the third dose.97.5% CI: [0.88, 1.55]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 7F concentrations one month after the third dose.97.5% CI: [0.91, 1.34]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 9V concentrations one month after the third dose.97.5% CI: [1, 1.55]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 14 concentrations one month after the third dose.97.5% CI: [0.9, 1.5]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 18C concentrations one month after the third dose.97.5% CI: [1.01, 1.52]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19A concentrations one month after the third dose.97.5% CI: [0.94, 1.43]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 19F concentrations one month after the third dose.97.5% CI: [0.89, 1.29]ANCOVA
Comparison: GMC ratio between HibCY and PedHIB groups for antibodies to S. pneumoniae serotype 23F concentrations one month after the third dose.97.5% CI: [0.91, 1.53]ANCOVA
Primary
Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL
Percentage of subjects with Anti-Havrix (Anti-HAV) antibody concentrations was assessed. The cut-off value is ≥15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch
Time frame: 1 month post-dose 2 of Havrix (Month 17-20)
Population: The analysis was performed on the Havrix ATP cohort for analysis of immunogenicity which include all evaluable subjects who received two doses of Havrix vaccine and for whom immunogenicity results were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HibCY Group | Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Anti-Hepatitis A (Anti-Havrix) Antibody Concentrations ≥ 15mIU/mL | 100 Percentage of subjects |
Comparison: Difference between HibCY and PedHIB groups in percentage of subjects with anti-HAV concentrations equal to or above the cut-off value of 15 mIU/mL one month after the second Havrix dose.97.5% CI: [-3.76, 3.91]Group difference in proportions
Primary
Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL
Percentage of subjects with Anti-PRP antibody concentrations≥1.0 µg/mL were assessed. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts. Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.As per an hierarchical procedure, the primary objective about Anti-PRP will first need to be met to be able to conclude on any other primary objective, and within each subsequent arm, the first primary objective will have to be reached to conclude on the second primary objective of that Epoch.
Time frame: 1 month after the fourth dose for HibCY Group and 1 month after third dose for PedHIB Group [Month (M) 11-14]
Population: The analysis was performed on the Fourth dose According to Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who have received 3 vaccine doses in the first 3-doses vaccination course and who have received the fourth vaccine dose and the first Havrix dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HibCY Group | Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL | 98.2 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 1.0 µg/mL | 97.2 Percentage of subjects |
Comparison: Difference between HibCY and PedHIB groups in percentage of subjects with anti-PRP concentrations equal to or above the cut-off value of 1.0 µg/mL one month after the fourth dose in HibCY Group and third dose in PedHIB Group.95% CI: [-2.12, 4.3]Group difference in proportions
Secondary
Anti-HAV GMCs ≥ 15 mIU/mL
The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups
Time frame: 1 month post-dose 1 of HAV (M11-14).
Population: The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HibCY Group | Anti-HAV GMCs ≥ 15 mIU/mL | 44.8 mIU/mL |
| PedHIB Group | Anti-HAV GMCs ≥ 15 mIU/mL | 47.3 mIU/mL |
Secondary
Anti-PRP GMCs≥ 0.15 µg/mL.
Anti-PRP antibody concentrations were assessed by Enzyme-Linked-Immunosorbent-Assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in micrograms per mililiter (µg/mL).The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.
Time frame: 2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Month 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]
Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HibCY Group | Anti-PRP GMCs≥ 0.15 µg/mL. | Month 5 | 8.414 µg/mL |
| HibCY Group | Anti-PRP GMCs≥ 0.15 µg/mL. | Month 11-14 | 28.090 µg/mL |
| PedHIB Group | Anti-PRP GMCs≥ 0.15 µg/mL. | Month 4 | 11.053 µg/mL |
| PedHIB Group | Anti-PRP GMCs≥ 0.15 µg/mL. | Month 11-14 | 20.869 µg/mL |
Secondary
Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY
The cut-off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.
Time frame: 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).
Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HibCY Group | Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY | hSBA-MenC, Month 5 | 807.3 Titres |
| HibCY Group | Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY | hSBA-MenY, Month 5 | 510.9 Titres |
| HibCY Group | Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY | hSBA-MenC, Month 11-14 | 2566.2 Titres |
| HibCY Group | Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY | hSBA-MenY, Month 11-14 | 2761.4 Titres |
| PedHIB Group | Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY | hSBA-MenY, Month 11-14 | 2728.2 Titres |
| PedHIB Group | Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY | hSBA-MenC, Month 5 | 2.1 Titres |
| PedHIB Group | Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY | hSBA-MenC, Month 11-14 | 2.0 Titres |
| PedHIB Group | Geometric Mean Titres (GMTs) of Human Complement Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and to hSBA-MenY | hSBA-MenY, Month 5 | 550.2 Titres |
Secondary
GMCs for Anti-HAV Antibodies ≥15mIU/mL.
The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups
Time frame: 1 month post-dose 2 of HAV (Month 17-20).
Population: This analysis was performed on Havrix ATP cohort for analysis of immunogenicity which included all evaluable subjects who have received the first and second dose of Havrix and for whom assay results were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HibCY Group | GMCs for Anti-HAV Antibodies ≥15mIU/mL. | 1590.7 mIU/mL |
| PedHIB Group | GMCs for Anti-HAV Antibodies ≥15mIU/mL. | 1390.6 mIU/mL |
Secondary
Percentage of Subjects Reporting Any Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Day 0 to Month 17-20)
Population: The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HibCY Group | Percentage of Subjects Reporting Any Serious Adverse Events (SAEs). | 2.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Serious Adverse Events (SAEs). | 3.6 Percentage of subjects |
Secondary
Percentage of Subjects Reporting Any Solicited General AEs.
Solicited general AEs include fever \[defined as temperature ≥38.0 degrees Celsius (°C) by any method\], drowsiness, irritability/fussiness and loss of appetite.
Time frame: 4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose.
Population: The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Any Temperature (°C), Dose 1 | 11.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Any Temperature (°C), Dose 2 | 19.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Any Temperature (°C), Dose 3 | 16.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Any Temperature (°C), Dose 4 | 8.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Irritability / Fussiness, Dose 1 | 71.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Irritability / Fussiness, Dose 2 | 70.0 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Irritability / Fussiness, Dose 3 | 66.0 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Irritability / Fussiness, Dose 4 | 66.0 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Loss Of Appetite, Dose 1 | 31.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Loss Of Appetite, Dose 2 | 29.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Loss Of Appetite, Dose 3 | 29.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Loss Of Appetite, Dose 4 | 33.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Drowsiness, Dose 1 | 64.9 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Drowsiness, Dose 2 | 54.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Drowsiness, Dose 3 | 48.9 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited General AEs. | Drowsiness, Dose 4 | 44.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Drowsiness, Dose 4 | 48.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Any Temperature (°C), Dose 1 | 20.6 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Loss Of Appetite, Dose 1 | 42.3 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Any Temperature (°C), Dose 2 | 29.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Drowsiness, Dose 1 | 70.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Any Temperature (°C), Dose 3 | 17.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Loss Of Appetite, Dose 2 | 31.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Any Temperature (°C), Dose 4 | 10.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Drowsiness, Dose 3 | 52.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Irritability / Fussiness, Dose 1 | 81.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Loss Of Appetite, Dose 3 | 28.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Irritability / Fussiness, Dose 2 | 83.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Drowsiness, Dose 2 | 65.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Irritability / Fussiness, Dose 3 | 69.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Loss Of Appetite, Dose 4 | 39.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited General AEs. | Irritability / Fussiness, Dose 4 | 74.3 Percentage of subjects |
Secondary
Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE).
Solicited local adverse events include pain, redness and swelling at injection site.
Time frame: 4 days (Day 0 to Day 3) after all vaccines post-primary and post-fourth dose
Population: This analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose total vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Prevnar 13, Dose 4 | 26.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Hib-MenCY-TT/PedvaxHIB, Dose 1 | 44.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Prevnar 13, Dose 1 | 46.3 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Hib-MenCY-TT/PedvaxHIB, Dose 2 | 45.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Pediarix, Dose 2 | 45.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Prevnar 13, Dose 2 | 44.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Hib-MenCY-TT/PedvaxHIB, Dose 3 | 38.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Pediarix, Dose 3 | 42.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Prevnar 13, Dose 3 | 39.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain,Havrix , Dose 4 | 44.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Hib-MenCY-TT/PedvaxHIB, Dose 4 | 42.3 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Prevnar 13, Dose 4 | 41.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Hib-MenCY-TT/PedvaxHIB, Dose 1 | 21.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Pediarix, Dose 1 | 27.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Prevnar 13, Dose 1 | 23.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Hib-MenCY-TT/PedvaxHIB, Dose 2 | 30.3 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Pediarix, Dose 2 | 33.9 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Prevnar 13, Dose 2 | 30.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Hib-MenCY-TT/PedvaxHIB, Dose 3 | 31.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Pediarix, Dose 3 | 38.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Prevnar 13, Dose 3 | 36.3 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness,Havrix , Dose 4 | 38.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Hib-MenCY-TT/PedvaxHIB, Dose 4 | 38.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Prevnar 13, Dose 4 | 41.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 1 | 11.3 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Pediarix, Dose 1 | 18.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Prevnar 13, Dose 1 | 14.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 2 | 18.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Pediarix, Dose 2 | 22.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Prevnar 13, Dose 2 | 22.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 3 | 19.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Pediarix, Dose 3 | 29.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Prevnar 13, Dose 3 | 24.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling,Havrix , Dose 4 | 25.3 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 4 | 22.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Pediarix, Dose 1 | 50.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Hib-MenCY-TT/PedvaxHIB, Dose 1 | 61.2 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Prevnar 13, Dose 2 | 41.2 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Pediarix, Dose 1 | 57.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Prevnar 13, Dose 1 | 16.2 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Prevnar 13, Dose 1 | 58.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Pediarix, Dose 3 | 37.9 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Hib-MenCY-TT/PedvaxHIB, Dose 2 | 56.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Pediarix, Dose 3 | 50.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Pediarix, Dose 2 | 55.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 2 | 30.6 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Prevnar 13, Dose 2 | 56.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Prevnar 13, Dose 3 | 45.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Prevnar 13, Dose 4 | 27.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Pediarix, Dose 3 | 50.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness,Havrix , Dose 4 | 43.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Prevnar 13, Dose 3 | 47.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Pediarix, Dose 2 | 36.3 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain,Havrix , Dose 4 | 50.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Hib-MenCY-TT/PedvaxHIB, Dose 4 | 50.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Hib-MenCY-TT/PedvaxHIB, Dose 4 | 56.2 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Prevnar 13, Dose 3 | 31.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Pain, Prevnar 13, Dose 4 | 46.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Prevnar 13, Dose 4 | 44.6 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Hib-MenCY-TT/PedvaxHIB, Dose 1 | 35.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Prevnar 13, Dose 2 | 28.9 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Pediarix, Dose 1 | 25.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 1 | 22.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Prevnar 13, Dose 1 | 24.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Hib-MenCY-TT/PedvaxHIB, Dose 4 | 34.3 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Hib-MenCY-TT/PedvaxHIB, Dose 2 | 41.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling, Pediarix, Dose 1 | 16.2 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Redness, Pediarix, Dose 2 | 43.2 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Solicited Local Adverse Events (AE). | Swelling,Havrix , Dose 4 | 26.0 Percentage of subjects |
Secondary
Percentage of Subjects Reporting Any Unsolicited AEs.
Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited adverse event.
Time frame: During 31 days (Day 0 to Day 30) after all vaccines post-primary (Dose 1-3) and post-fourth dose (Dose 4)
Population: The analysis was performed on First three doses Total Vaccinated cohort and on the Fourth dose Total Vaccinated cohort which included all evaluable subjects who received atleast one dose of any of the study vaccines:Hib-MenCY-TT, Pediarix, Prevnar 13, Rotarix, PedvaxHIB or Havrix, and with the vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HibCY Group | Percentage of Subjects Reporting Any Unsolicited AEs. | Dose 1-3 | 60.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects Reporting Any Unsolicited AEs. | Dose 4 | 39.9 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Unsolicited AEs. | Dose 1-3 | 56.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects Reporting Any Unsolicited AEs. | Dose 4 | 42.0 Percentage of subjects |
Secondary
Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL
The cut-off value is 15 mIU/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.
Time frame: 1 month post-dose 1 of Havrix (Month 11-14)
Population: The analysis was performed on the Fourth dose ATP cohort for analysis of immunogenicity, which included all vaccinated subjects for whom data are available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HibCY Group | Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL | 85.2 percentage of subjects |
| PedHIB Group | Percentage of Subjects With Anti-HAV Antibodies ≥ 15 mIU/mL | 89.3 percentage of subjects |
Secondary
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL.
The cut-off value for this assay was 0.15 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.
Time frame: 2 months post-dose 2 [PedHib Group only (Month 4)], 1 month post-dose 3 (Month 5 for HibCY group and Months 11-14 for PedHib Group) and 1 month post-dose 4 [HibCY Group only (Month 11-14)]
Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months 11-14) which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HibCY Group | Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL. | Month 5 | 99.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL. | Month 11-14 | 99.6 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL. | Month 4 | 98.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Anti-PRP Antibody Concentrations ≥0.15 µg/mL. | Month 11-14 | 100 Percentage of subjects |
Secondary
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL
The cut-off value for this assay was 1.0 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.
Time frame: 2 months post-dose 2 [PedHib group only (Month 4)] and 1 month postdose 3 [HibCY group only (Month 5)].
Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 4 and Month 5) which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HibCY Group | Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL | Month 5 | 94.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Anti-PRP Antibody Concentrations ≥1.0 µg/mL | Month 4 | 91.5 Percentage of subjects |
Secondary
Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL
The cut-off value is 20 Units (U)/mL Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.
Time frame: 2 month post-dose 2 of Rotarix (Month 4)
Population: The analysis was performed on the Rota ATP cohort for analysis of immunogenicity which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HibCY Group | Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL | 81.3 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Anti-rotavirus IgA Antibody Concentrations ≥ 20 Units (U)/mL | 80.1 Percentage of subjects |
Secondary
Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32.
The cut off values are dilutions of 1:8, 1:16 and 1:32. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups.
Time frame: 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14).
Population: The analysis was performed on the First three doses ATP cohort for analysis of immunogenicity (for Month 5) and the Fourth doses ATP cohort for analysis of immunogenicity (for Months11-14) which included all evaluable subjects for whom immunogenicity results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 11-14, ≥ 8 | 99.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 5, ≥ 16 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 11-14, ≥ 16 | 98.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 5, ≥ 8 | 97.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 11-14, ≥ 32 | 98.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 5, ≥ 8 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 11-14, ≥ 8 | 98.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 5, ≥ 16 | 97.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 11-14, ≥ 16 | 98.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 5, ≥ 32 | 99.3 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 11-14, ≥ 32 | 98.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 5, ≥ 32 | 97.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 11-14, ≥ 32 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 5, ≥ 8 | 1.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 5, ≥ 16 | 1.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 5, ≥ 32 | 0.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 5, ≥ 8 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 5, ≥ 16 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 11-14, ≥ 8 | 0.6 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 11-14, ≥ 16 | 0.6 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenC, Month 11-14, ≥ 32 | 0.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 11-14, ≥ 8 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 11-14, ≥ 16 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With Serum Bactericidal Assay to N. Meningitidis Serogroup C (hSBA-MenC) and N. Meningitidis Serogroup Y (hSBA-MenY) Antibody Titers ≥1:8, ≥1:16, ≥1:32. | hSBA-MenY, Month 5, ≥ 32 | 100 Percentage of subjects |
Secondary
Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
The cut-off values are 0.15, 0.26, 0.35 µg/mL. Analysis of Immunogenicity is performed on blood sample (BS) sub-cohorts.Assignment to a BS sub-cohort depends on the date of enrolment of the subject: BS sub-cohort for the first 200 , for the next 200 subjects or for the last 200 subjects. Within each BS sub-cohort subjects have been randomized 1:1 to either HibCY or PedHIB groups
Time frame: 1 month post-dose 3 (Month 5) and 1 month post-dose 4 (Month 11-14)
Population: This analysis was perfomed on First three doses ATP for analysis of immunogenicity and on the Fourth dose ATP cohort for analysis of immunogenicity which included all evaluable subjects for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 5, ≥ 0.35 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 11-14, ≥ 0.26 | 99.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 5, ≥ 0.15 | 96.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 11-14, ≥0.35 | 97.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 5, ≥ 0.15 | 99.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 11-14, ≥ 0.15 | 97.0 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 5, ≥ 0.35 | 91.0 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 11-14, ≥ 0.26 | 85.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 5, ≥ 0.26 | 92.9 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 11-14, ≥0.35 | 71.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 5, ≥ 0.15 | 98.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 5, ≥ 0.35 | 83.3 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 11-14, ≥ 0.26 | 98.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 11-14, ≥0.35 | 97.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 5, ≥ 0.35 | 96.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 11-14, ≥ 0.26 | 99.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 5, ≥ 0.26 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 11-14, ≥0.35 | 99.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 5, ≥ 0.26 | 98.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 5, ≥ 0.35 | 99.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 5, ≥ 0.26 | 96.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 5, ≥ 0.35 | 98.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 5, ≥ 0.26 | 96.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 5, ≥ 0.26 | 84.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 5, ≥ 0.35 | 87.2 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 5, ≥ 0.15 | 95.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 5, ≥ 0.35 | 91.0 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 11-14, ≥ 0.26 | 99.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 5, ≥ 0.26 | 99.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 11-14, ≥0.35 | 97.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 5, ≥ 0.26 | 90.9 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 11-14, ≥ 0.15 | 99.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 5, ≥ 0.35 | 97.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 11-14, ≥ 0.26 | 99.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 5, ≥ 0.26 | 98.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 11-14, ≥0.35 | 99.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 5, ≥ 0.35 | 83.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 11-14, ≥ 0.26 | 99.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 5, ≥ 0.26 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 11-14, ≥0.35 | 98.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 5, ≥ 0.15 | 97.4 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 5, ≥ 0.35 | 98.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 5, ≥ 0.15 | 96.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 5, ≥ 0.35 | 69.8 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 5, ≥ 0.26 | 91.7 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 5, ≥ 0.26 | 100 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 11-14, ≥ 0.15 | 99.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 5, ≥ 0.35 | 83.3 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 11-14, ≥ 0.26 | 99.5 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 5, ≥ 0.26 | 93.6 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 11-14, ≥0.35 | 98.1 Percentage of subjects |
| HibCY Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 5, ≥ 0.26 | 98.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 5, ≥ 0.35 | 93.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 5, ≥ 0.15 | 94.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 5, ≥ 0.26 | 78.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 5, ≥ 0.35 | 69.3 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 5, ≥ 0.15 | 98.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 5, ≥ 0.26 | 91.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 5, ≥ 0.35 | 84.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 5, ≥ 0.15 | 96.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 5, ≥ 0.26 | 86.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 5, ≥ 0.35 | 80.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 5, ≥ 0.15 | 98.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 5, ≥ 0.26 | 94.3 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 5, ≥ 0.35 | 91.8 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 5, ≥ 0.15 | 93.7 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 5, ≥ 0.26 | 86.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 5, ≥ 0.35 | 80.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 5, ≥ 0.26 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 5, ≥ 0.35 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 5, ≥ 0.15 | 94.9 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 5, ≥ 0.26 | 86.6 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 5, ≥ 0.35 | 76.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 5, ≥ 0.15 | 99.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 5, ≥ 0.26 | 98.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 5, ≥ 0.35 | 97.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 5, ≥ 0.15 | 98.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 5, ≥ 0.26 | 91.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 5, ≥ 0.35 | 82.3 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 5, ≥ 0.15 | 98.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 5, ≥ 0.26 | 93.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 5, ≥ 0.35 | 90.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 5, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 5, ≥ 0.26 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 5, ≥ 0.35 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 5, ≥ 0.15 | 96.2 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 5, ≥ 0.26 | 84.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 5, ≥ 0.35 | 77.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 11-14, ≥ 0.26 | 99.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-1 antibody, Month 11-14, ≥0.35 | 97.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 11-14, ≥ 0.15 | 94.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 11-14, ≥ 0.26 | 81.4 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-3 antibody, Month 11-14, ≥0.35 | 69.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 11-14, ≥ 0.15 | 98.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 11-14, ≥ 0.26 | 97.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-4 antibody, Month 11-14, ≥0.35 | 94.1 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 11-14, ≥ 0.26 | 99.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-5 antibody, Month 11-14, ≥0.35 | 98.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6A antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-6B antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 11-14, ≥ 0.26 | 99.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-7F antibody, Month 11-14, ≥0.35 | 99.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 11-14, ≥ 0.15 | 99.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 11-14, ≥ 0.26 | 98.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-9V antibody, Month 11-14, ≥0.35 | 96.6 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-14 antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 11-14, ≥ 0.26 | 99.0 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-18C antibody, Month 11-14, ≥0.35 | 97.5 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19A antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-19F antibody, Month 11-14, ≥0.35 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 11-14, ≥ 0.15 | 100 Percentage of subjects |
| PedHIB Group | Percentage of Subjects With S. Pneumoniae Antibody Concentrations ≥ 0.15 µg/mL, ≥ 0.26 µg/mL and ≥ 0.35 µg/mL for Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Anti-23F antibody, Month 11-14, ≥ 0.26 | 100 Percentage of subjects |