Acellular Pertussis, Diphtheria, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis, Tetanus
Conditions
Keywords
Pertussis, Immunogenicity, Poliomyelitis, Tetanus, Hepatitis B, Diptheria
Brief summary
The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks. All infants in this booster study were born to pregnant women who participated in the study 116945 \[DTPA (BOOSTRIX)-047\] and having received the full primary vaccination series as per protocol requirement in study 201330 \[DTPA (BOOSTRIX)-048.
Interventions
BIOLOGICALInfanrix hexa
All subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 19 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects' parent(s)/Legally acceptable representatives (LAR(s)) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. * A male or female child 9 months of age at the time of enrolment. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects born to mothers who were vaccinated in 116945 \[DTPA (BOOSTRIX)-047\] study and having completed their primary vaccination series as per protocol requirement in study 201330 \[DTPA (BOOSTRIX)-048 PRI\].
Exclusion criteria
* Child in care * Concurrently participating in another clinical study, within three months prior to the booster vaccine dose and at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period within six months prior to the booster vaccine dose. For corticosteroids, this will mean prednisone ≥0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. * Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab). * A vaccine not foreseen by the study protocol administered during the period starting from 30 days before the booster dose of study vaccine and ending 30 days after\*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunization schedule, that are allowed at any time during the study period. * In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its SPC or Product Information (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Major congenital defects. * Serious chronic illness. * Administration of immunoglobulins and/or any blood products during the period within three months before the booster dose of study vaccines or planned administration during the study period. * Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination with Infanrix hexa and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours. * History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases since the conclusion visit of study 201330 \[DTPA (BOOSTRIX)-048 PRI\]. * Previous booster vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or poliovirus since the conclusion visit of study 201330 \[DTPA (BOOSTRIX)-048 PRI\]. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (e.g: antigen, excipients). * Hypersensitivity to latex. * History of any neurological disorders or seizures. * Any condition that in the judgment of the investigator would make intramuscular injection unsafe. * Acute disease and/or fever at the time of vaccination. * Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | At one month after the booster dose (Day 30) | Seroprotected subjects were defined as subjects with antibody concentrations/titres above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 International units per milliliter (IU/ml) for anti-D and anti-T, 10 milli-International units per milliliter (mIU/mL) for anti-HB's, 8 Effective Dose 50 (ED50) for anti-polio virus (type 1,2,3) and 0.15 microgram/milliliter (µg/mL) for anti-PRP were considered as immunological correlates of protection. |
| Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | At one month after the booster dose (Day 30) | Booster response to PT, FHA and PRN antigens was defined as: * for subjects with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off, * for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and * for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration Seronegative (S-) subjects are those who have antibody concentration less than (\<) assay cut-off. Seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Before the booster dose (Day 0) | Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off's for anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) are 0.080 µg/mL, 0.075 µg/mL, 0.061 µg/mL, 0.198 µg/mL, 0.111 µg/mL, 0.102 µg/mL, 0.063 µg/mL, 0.66 µg/mL, 0.160 µg/mL, 0.111 µg/mL, 0.199 µg/mL, 0.163 µg/mL, 0.073 µg/mL respectively. |
| Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL. |
| Anti-poliovirus Type 1, 2, 3 Antibody Titres | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Anti-Poliovirus type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMT). |
| Anti-HBs Antibody Concentrations | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in mIU/mL. |
| Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in µg/mL. |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | At one month after the booster dose (Day 30) | Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN |
| Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Before the booster dose (Day 0) | Seroprotected subjects were defined as subjects with antibody concentrations/titers above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 IU/mL for anti-D and anti-T, 10 mIU/mL for anti-HB's, 8 ED50 for anti-polio virus (type 1,2,3) and 0.15 µg/mL for anti-PRP were considered as immunological correlates of protection. |
| Number of Subjects With Solicited General Symptoms | During the 4-day (Day 0-Day 3) follow-up period after booster vaccination | Assessed solicited general symptoms were Drowsiness, Fever, Irritability/Fussiness and Loss of appetite. Fever was defined as temperature ≥37.5 degree Celsius (°C) /99.5 degree Fahrenheit (°F) for oral, axillary or tympanic route, or ≥38.0°C/100.4°F on rectal route. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Day 0-Day 30) follow-up period after booster vaccination | An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Number of Subjects With Serious Adverse Events (SAEs) | From booster dose up to study end (approximately 6 or 7 months, per subject) | SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, resulting in disability/incapacity |
| Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | At 9 months of age, 18 months of age, and 9 or 18 months of age | Neurodevelopmental status was measured by ASQ-3 score scale \[ASQ-3, 2016\] in the black zone. The ASQ-3 included a series of questions designed to assess 5 areas of development (communication, gross motor, fine motor, problem solving, and personal-social). Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was to be referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III \[BSID-III\]) |
| Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) | At 9 months of age, 18 months of age, and 9 or 18 months of age | Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III BSID-III) |
| Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) | At 9 months of age, 18 months of age, and 9 or 18 months of age | The estimated proportion (expressed in percentage) of infants with a BSID-III indicator of neurodevelopmental delay was based on ASQ-3 black zone indicator and subsequent BSID-III assessment using the following formula: 100 \* (Number of subjects with ASQ-3 below cut off / Number of enrolled subjects with available results) \* (Number of subjects with at least one indicator of neurodevelopmental delay using BSID III / Number of subjects referred for BSID III evaluation) |
| Number of Subjects With Solicited Local Symptoms | During the 4-day (Day 0-Day 3) follow-up period after booster vaccination of two vaccines (Infanrix hexa and Prevenar 13) | Assessed solicited local symptoms were pain, redness, swelling. Any redness, swelling is defined as a symptom with a surface diameter greater than 0 millimeter |
| Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Before the booster dose (Day 0) | Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN |
Countries
Australia, Canada, Czechia, Finland, Italy, Spain
Participant flow
Recruitment details
Subjects enrolled in the study were infants aged 9 months at the time of enrollment, born to mothers vaccinated with Boostrix in study 116945 BOOSTRIX-047 \[NCT02377349\] and who received primary vaccination Infanrix hexa co-administered with Prevenar 13 in study 201330 BOOSTRIX-048 \[NCT0242264\]
Pre-assignment details
551 subjects were enrolled in this trial, out of which 540 received the booster dose of Infanrix hexa co-administered with Prevenar 13. 11 subjects did not receive booster vaccination even though subject number had been allocated.
Participants by arm
| Arm | Count |
|---|---|
| dTpa Group This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery.
All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure | 270 |
| Control Group This group included healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery.
All enrolled subjects in this group who came back for subsequent visit received a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure | 281 |
| Total | 551 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Subjects enrolled but not vaccinated | 7 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control Group | Total | dTpa Group |
|---|---|---|---|
| Age, Customized Infants and toddlers (28 days-23 months) | 281 Participants | 551 Participants | 270 Participants |
| Race/Ethnicity, Customized African Heritage / African American | 9 Participants | 13 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 7 Participants | 23 Participants | 16 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 262 Participants | 508 Participants | 246 Participants |
| Sex: Female, Male Female | 128 Participants | 255 Participants | 127 Participants |
| Sex: Female, Male Male | 153 Participants | 296 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 263 | 0 / 277 |
| other Total, other adverse events | 232 / 263 | 257 / 277 |
| serious Total, serious adverse events | 0 / 263 | 3 / 277 |
Outcome results
Primary
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
Seroprotected subjects were defined as subjects with antibody concentrations/titres above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 International units per milliliter (IU/ml) for anti-D and anti-T, 10 milli-International units per milliliter (mIU/mL) for anti-HB's, 8 Effective Dose 50 (ED50) for anti-polio virus (type 1,2,3) and 0.15 microgram/milliliter (µg/mL) for anti-PRP were considered as immunological correlates of protection.
Time frame: At one month after the booster dose (Day 30)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-D | 221 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-polio 1 | 204 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-polio 2 | 201 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-HBs | 215 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-polio 3 | 188 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-T | 221 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-PRP | 221 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-HBs | 239 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-polio 1 | 228 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-PRP | 246 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-D | 247 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-T | 247 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-polio 2 | 227 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Anti-polio 3 | 210 Participants |
Primary
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN))
Booster response to PT, FHA and PRN antigens was defined as: * for subjects with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off, * for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and * for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration Seronegative (S-) subjects are those who have antibody concentration less than (\<) assay cut-off. Seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN
Time frame: At one month after the booster dose (Day 30)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PT, S- | 62 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PRN, S- | 34 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PRN, S+ (≥ 4*assay cut-off) | 86 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PT, S+ (< 4*assay cut-off) | 98 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PT, S+ (≥ 4*assay cut-off) | 38 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PT, Overall | 198 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-FHA, S- | 8 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-FHA, S+ (< 4*assay cut-off) | 83 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-FHA, S+ (≥ 4*assay cut-off) | 117 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-FHA, Overall | 208 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PRN, S+ (< 4*assay cut-off) | 90 Participants |
| dTpa Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PRN, Overall | 210 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PRN, Overall | 240 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-FHA, S+ (< 4*assay cut-off) | 58 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PRN, S+ (< 4*assay cut-off) | 76 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PT, S- | 40 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-FHA, S+ (≥ 4*assay cut-off) | 172 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PT, S+ (< 4*assay cut-off) | 124 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PRN, S+ (≥ 4*assay cut-off) | 133 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PT, S+ (≥ 4*assay cut-off) | 71 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-FHA, Overall | 233 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PT, Overall | 235 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-PRN, S- | 31 Participants |
| Control Group | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | Anti-FHA, S- | 3 Participants |
Secondary
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL.
Time frame: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-D at Day 0 | 0.207 IU/ml |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PRN at Day 0 | 6.9 IU/ml |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PRN at Day 30 | 333.9 IU/ml |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-D at Day 30 | 6.114 IU/ml |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-T at Day 0 | 0.753 IU/ml |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-T at Day 30 | 8.200 IU/ml |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PT at Day 0 | 4.4 IU/ml |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PT at Day 30 | 52.4 IU/ml |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-FHA at Day 0 | 11.2 IU/ml |
| dTpa Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-FHA at Day 30 | 152.5 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PT at Day 30 | 80.3 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-T at Day 30 | 6.758 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PRN at Day 0 | 9.6 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-FHA at Day 30 | 187.2 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PRN at Day 30 | 262.3 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-D at Day 0 | 0.322 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-PT at Day 0 | 6.3 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-D at Day 30 | 8.402 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-FHA at Day 0 | 16.5 IU/ml |
| Control Group | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Anti-T at Day 0 | 0.578 IU/ml |
Secondary
Anti-HBs Antibody Concentrations
Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in mIU/mL.
Time frame: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| dTpa Group | Anti-HBs Antibody Concentrations | Anti-HBs at Day 0 | 158.7 mIU/mL |
| dTpa Group | Anti-HBs Antibody Concentrations | Anti-HBs at Day 30 | 4858.3 mIU/mL |
| Control Group | Anti-HBs Antibody Concentrations | Anti-HBs at Day 0 | 193.4 mIU/mL |
| Control Group | Anti-HBs Antibody Concentrations | Anti-HBs at Day 30 | 5031.2 mIU/mL |
Secondary
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations
Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in µg/mL.
Time frame: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 3 at Day 0 | 0.08 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 3 at Day 30 | 0.59 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 4 at Day 30 | 2.91 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 6B at Day 0 | 0.29 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 6B at Day 30 | 7.83 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 7F at Day 0 | 0.49 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 7F at Day 30 | 5.00 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 19F at Day 30 | 7.66 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PRP at Day 0 | 0.371 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 1 at Day 0 | 0.22 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 1 at Day 30 | 3.22 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 4 at Day 0 | 0.15 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 5 at Day 0 | 0.33 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 5 at Day 30 | 2.66 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 6A at Day 0 | 0.38 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 6A at Day 30 | 9.07 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 9V at Day 0 | 0.26 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 9V at Day 30 | 3.74 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 14 at Day 0 | 0.97 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 14 at Day 30 | 10.36 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 18C at Day 0 | 0.19 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 18C at Day 30 | 3.23 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 19A at Day 0 | 0.32 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 19A at Day 30 | 7.90 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 19F at Day 0 | 0.37 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 23F at Day 0 | 0.14 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 23F at Day 30 | 2.07 µg/mL |
| dTpa Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PRP at Day 30 | 26.186 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 18C at Day 30 | 3.57 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 3 at Day 0 | 0.10 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 6A at Day 0 | 0.44 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 4 at Day 0 | 0.19 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 23F at Day 30 | 2.38 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 6A at Day 30 | 9.49 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 19A at Day 0 | 0.37 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 6B at Day 0 | 0.33 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 9V at Day 0 | 0.32 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 6B at Day 30 | 8.00 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 23F at Day 0 | 0.19 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 7F at Day 0 | 0.56 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 9V at Day 30 | 3.91 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 7F at Day 30 | 4.96 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 19A at Day 30 | 8.68 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 14 at Day 0 | 1.19 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PRP at Day 0 | 0.292 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PRP at Day 30 | 19.714 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 1 at Day 0 | 0.27 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 14 at Day 30 | 11.62 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 1 at Day 30 | 3.64 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 3 at Day 30 | 0.62 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 19F at Day 0 | 0.47 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 4 at Day 30 | 3.28 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 18C at Day 0 | 0.23 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 5 at Day 0 | 0.34 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 19F at Day 30 | 8.63 µg/mL |
| Control Group | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Anti-PnPS 5 at Day 30 | 2.81 µg/mL |
Secondary
Anti-poliovirus Type 1, 2, 3 Antibody Titres
Anti-Poliovirus type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMT).
Time frame: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| dTpa Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 1 at Day 0 | 64.9 Titers |
| dTpa Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 1 at Day 30 | 1611.7 Titers |
| dTpa Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 2 at Day 0 | 71.7 Titers |
| dTpa Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 2 at Day 30 | 2232.4 Titers |
| dTpa Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 3 at Day 0 | 106.0 Titers |
| dTpa Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 3 at Day 30 | 2944.6 Titers |
| Control Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 3 at Day 0 | 118.4 Titers |
| Control Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 1 at Day 0 | 83.3 Titers |
| Control Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 2 at Day 30 | 2371.2 Titers |
| Control Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 1 at Day 30 | 1532.1 Titers |
| Control Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 3 at Day 30 | 2891.8 Titers |
| Control Group | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Anti-polio 2 at Day 0 | 79.2 Titers |
Secondary
Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III)
The estimated proportion (expressed in percentage) of infants with a BSID-III indicator of neurodevelopmental delay was based on ASQ-3 black zone indicator and subsequent BSID-III assessment using the following formula: 100 \* (Number of subjects with ASQ-3 below cut off / Number of enrolled subjects with available results) \* (Number of subjects with at least one indicator of neurodevelopmental delay using BSID III / Number of subjects referred for BSID III evaluation)
Time frame: At 9 months of age, 18 months of age, and 9 or 18 months of age
Population: The analysis was performed on Total enrolled cohort, which included enrolled subjects with available results.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| dTpa Group | Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) | Any domain at Month 9 | 4.39 Percentage of Infants |
| dTpa Group | Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) | Any domain at Month 18 | 1.17 Percentage of Infants |
| dTpa Group | Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) | Any domain at Month 9 or 18 | 4.61 Percentage of Infants |
| Control Group | Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) | Any domain at Month 9 | 5.69 Percentage of Infants |
| Control Group | Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) | Any domain at Month 18 | 0.61 Percentage of Infants |
| Control Group | Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III) | Any domain at Month 9 or 18 | 5.84 Percentage of Infants |
Secondary
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)
Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off's for anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) are 0.080 µg/mL, 0.075 µg/mL, 0.061 µg/mL, 0.198 µg/mL, 0.111 µg/mL, 0.102 µg/mL, 0.063 µg/mL, 0.66 µg/mL, 0.160 µg/mL, 0.111 µg/mL, 0.199 µg/mL, 0.163 µg/mL, 0.073 µg/mL respectively.
Time frame: Before the booster dose (Day 0)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 1 | 196 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 9V | 203 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 19F | 183 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 23F | 160 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 3 | 122 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 4 | 189 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 5 | 163 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 6A | 196 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 6B | 175 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 7F | 210 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 14 | 201 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 18C | 168 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 19A | 148 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 18C | 190 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 1 | 214 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 5 | 182 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 6A | 219 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 19A | 172 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 14 | 223 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 19F | 202 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 6B | 205 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 23F | 191 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 3 | 147 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 7F | 232 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 4 | 215 Participants |
| Control Group | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Anti-pneumococcal serotype 9V | 225 Participants |
Secondary
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN
Time frame: Before the booster dose (Day 0)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 153 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 215 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 187 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PT | 201 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-FHA | 241 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Anti-PRN | 213 Participants |
Secondary
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN
Time frame: At one month after the booster dose (Day 30)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 220 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 220 Participants |
| dTpa Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 221 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PRN | 247 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-PT | 247 Participants |
| Control Group | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | Anti-FHA | 247 Participants |
Secondary
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP.
Seroprotected subjects were defined as subjects with antibody concentrations/titers above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 IU/mL for anti-D and anti-T, 10 mIU/mL for anti-HB's, 8 ED50 for anti-polio virus (type 1,2,3) and 0.15 µg/mL for anti-PRP were considered as immunological correlates of protection.
Time frame: Before the booster dose (Day 0)
Population: Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-PRP | 161 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-T | 215 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-HBs | 206 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-polio 1 | 188 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-polio 2 | 188 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-polio 3 | 188 Participants |
| dTpa Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-D | 181 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-polio 2 | 215 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-D | 220 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-PRP | 166 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-polio 1 | 212 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-T | 232 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-polio 3 | 215 Participants |
| Control Group | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Anti-HBs | 229 Participants |
Secondary
Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III)
Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III BSID-III)
Time frame: At 9 months of age, 18 months of age, and 9 or 18 months of age
Population: The analysis was performed on subjects from the Total enrolled cohort, who scored, below the defined cut-off in any of the 5 domains, when using the ASQ-3 score scale.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) | Any Domain at Month 9 | 16 Participants |
| dTpa Group | Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) | Any Domain at Month 18 | 6 Participants |
| dTpa Group | Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) | Any Domain at Month 9 or 18 | 20 Participants |
| Control Group | Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) | Any Domain at Month 18 | 3 Participants |
| Control Group | Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) | Any Domain at Month 9 or 18 | 17 Participants |
| Control Group | Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III) | Any Domain at Month 9 | 14 Participants |
Secondary
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone
Neurodevelopmental status was measured by ASQ-3 score scale \[ASQ-3, 2016\] in the black zone. The ASQ-3 included a series of questions designed to assess 5 areas of development (communication, gross motor, fine motor, problem solving, and personal-social). Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was to be referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III \[BSID-III\])
Time frame: At 9 months of age, 18 months of age, and 9 or 18 months of age
Population: The analysis was performed on Total enrolled cohort, which included enrolled subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Any domain at Month 9 or 18 | 31 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Gross motor skills at Month 9 | 14 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Fine motor at Month 18 | 1 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Personal- Social at Month 9 or 18 | 2 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Problem solving at Month 18 | 1 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Fine motor at Month 9 | 8 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Personal- Social at Month 18 | 0 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Any domain at Month 9 | 27 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Problem solving at Month 9 | 7 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Communication at Month 9 or 18 | 2 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Gross motor skills at Month 18 | 3 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Gross motor skills at Month 9 or 18 | 16 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Personal- Social at Month 9 | 2 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Fine motor at Month 9 or 18 | 9 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Communication at Month 9 | 1 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Problem solving at Month 9 or 18 | 8 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Any domain at Month 18 | 6 Participants |
| dTpa Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Communication at Month 18 | 1 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Personal- Social at Month 9 or 18 | 2 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Communication at Month 18 | 0 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Any domain at Month 9 | 28 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Communication at Month 9 | 3 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Gross motor skills at Month 9 | 19 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Fine motor at Month 9 | 3 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Problem solving at Month 9 | 6 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Personal- Social at Month 9 | 2 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Any domain at Month 18 | 5 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Gross motor skills at Month 18 | 2 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Fine motor at Month 18 | 1 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Problem solving at Month 18 | 3 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Personal- Social at Month 18 | 0 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Any domain at Month 9 or 18 | 31 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Communication at Month 9 or 18 | 3 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Gross motor skills at Month 9 or 18 | 20 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Fine motor at Month 9 or 18 | 4 Participants |
| Control Group | Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone | Problem solving at Month 9 or 18 | 8 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, resulting in disability/incapacity
Time frame: From booster dose up to study end (approximately 6 or 7 months, per subject)
Population: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dTpa Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were Drowsiness, Fever, Irritability/Fussiness and Loss of appetite. Fever was defined as temperature ≥37.5 degree Celsius (°C) /99.5 degree Fahrenheit (°F) for oral, axillary or tympanic route, or ≥38.0°C/100.4°F on rectal route.
Time frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination
Population: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with booster vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects With Solicited General Symptoms | Loss of Appetite | 104 Participants |
| dTpa Group | Number of Subjects With Solicited General Symptoms | Irritability | 163 Participants |
| dTpa Group | Number of Subjects With Solicited General Symptoms | Fever | 73 Participants |
| dTpa Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 128 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Fever | 85 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Irritability | 188 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Loss of Appetite | 116 Participants |
| Control Group | Number of Subjects With Solicited General Symptoms | Drowsiness | 138 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any redness, swelling is defined as a symptom with a surface diameter greater than 0 millimeter
Time frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination of two vaccines (Infanrix hexa and Prevenar 13)
Population: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and for those with booster vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| dTpa Group | Number of Subjects With Solicited Local Symptoms | Pain | 134 Participants |
| dTpa Group | Number of Subjects With Solicited Local Symptoms | Redness | 143 Participants |
| dTpa Group | Number of Subjects With Solicited Local Symptoms | Swelling | 119 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Swelling | 122 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Pain | 154 Participants |
| Control Group | Number of Subjects With Solicited Local Symptoms | Redness | 169 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: During the 31-day (Day 0-Day 30) follow-up period after booster vaccination
Population: The analysis was performed on the Total vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| dTpa Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 94 Participants |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 111 Participants |