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The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hibâ„¢ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INFANRIX-IPV+HIB 1 GROUP | Experimental | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrixâ„¢-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh. |
|
| INFANRIX-IPV+HIB 2 GROUP | Experimental | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrixâ„¢-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh. |
|
| INFANRIX-HIB+POLIORIX GROUP | Active Comparator | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrixâ„¢-Hib vaccine co-administered with Poliorixâ„¢ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infanrix-IPV/Hibâ„¢ | Biological | Intramuscular, three doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | One month after the third vaccine dose (Month 3 or Month 4) |
| Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL). | One month after the third vaccine dose (Month 3 or Month 4) |
| Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8. | One month after the third vaccine dose (Month 3 or Month 4) |
| Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination. | One month after the third vaccine dose (Month 3 or Month 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4) |
| Anti-PRP Antibody Concentrations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
• Current febrile illness or axillary temperature > 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wuzhou | Guangxi | 543002 | China | ||
| GSK Investigational Site |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Out of the 985 subjects originally enrolled in the study, 984 subjects were vaccinated with at least one dose of the study vaccine.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Infanrix-IPV+Hib 1 Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh. |
| FG001 | Infanrix-IPV+Hib 2 Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh. |
| FG002 | Infanrix-Hib+Poliorix Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Infanrix-IPV+Hib 1 Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens | A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | Count of Participants | Participants | One month after the third vaccine dose (Month 3 or Month 4) |
|
Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infanrix-IPV+Hib 1 Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enteritis | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| D004165 | Diphtheria |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Infanrix Hibâ„¢ | Biological | Intramuscular, three doses |
|
| Poliorixâ„¢ | Biological | Intramuscular, three doses |
|
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. |
| Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) |
| Anti-polio Types 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) |
| Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) |
| Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses |
| Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination. | During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) post-vaccination period after any dose |
| Number of Subjects With 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. | During the entire study period (from Month 0 to Month 4/5) |
| Wuzhou |
| Guangxi |
| 543100 |
| China |
| Adverse event, fatal |
|
| Adverse event, non-fatal |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Infanrix-IPV+Hib 2 Group |
Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh. |
| BG002 | Infanrix-Hib+Poliorix Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively. |
| BG003 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Infanrix-IPV+Hib 2 Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh. |
| OG002 | Infanrix-Hib+Poliorix Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively. |
|
|
|
| Primary | Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen | A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL). | The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | Count of Participants | Participants | One month after the third vaccine dose (Month 3 or Month 4) |
|
|
|
|
| Primary | Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens | A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8. | The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | Count of Participants | Participants | One month after the third vaccine dose (Month 3 or Month 4) |
|
|
|
|
| Primary | Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens | Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination. | The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | Count of Participants | Participants | One month after the third vaccine dose (Month 3 or Month 4) |
|
|
|
|
| Secondary | Anti-D and Anti-T Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4) |
|
|
|
| Secondary | Anti-PRP Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) |
|
|
|
| Secondary | Anti-polio Types 1, 2 and 3 Antibody Titers | Antibody titers were presented as geometric mean titers (GMTs). | The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) |
|
|
|
| Secondary | Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4) |
|
|
|
| Secondary | Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses |
|
|
|
| Secondary | Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses |
|
|
|
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) post-vaccination period after any dose |
|
|
|
| Secondary | Number of Subjects With 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. | The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. | Posted | Count of Participants | Participants | During the entire study period (from Month 0 to Month 4/5) |
|
|
|
| 1 |
| 330 |
| 6 |
| 330 |
| 279 |
| 330 |
| EG001 | Infanrix-IPV+Hib 2 Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh. | 0 | 324 | 3 | 324 | 277 | 324 |
| EG002 | Infanrix-Hib+Poliorix Group | Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively. | 0 | 330 | 4 | 330 | 272 | 330 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hepatitis neonatal | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Redness | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Drowsiness | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Loss of appetite | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Fever (Axillary) | General disorders | MedDRA 14.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Nasopharyngitis | General disorders | MedDRA 14.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| Title | Measurements |
|---|---|
|
| Anti-polio 3 |
|
| To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 2 antibodies, one month after the third vaccine dose. | Difference in seroprotection rate | 0 | 2-Sided | 95 | -2.51 | 2.56 | Non-Inferiority | Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%. |
| To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-Polio type 3 antibodies, one month after the third vaccine dose. | Difference in seroprotection rate | 0 | 2-Sided | 95 | -2.51 | 2.56 | Non-Inferiority | Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%. |
| Title | Measurements |
|---|---|
|
| Anti-PRN |
|
| To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-FHA antigens, one month after the third vaccine dose. | Difference in seroprotection rate | -2.7 | 2-Sided | 95 | -6.75 | -0.11 | Non-Inferiority | Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%. |
| To demonstrate that the immunogenicity of Infanrix™-IPV+Hib vaccine administered at 2, 3 and 4 months of age was non-inferior to that of the concomitant administration of Infanrix™-Hib and Poliorix™ vaccines at the same age, in terms of immune response to anti-PRN antigens, one month after the third vaccine dose. | Difference in seroprotection rate | -0.67 | 2-Sided | 95 | -4.6 | 3.04 | Non-Inferiority | Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% confidence interval (CI) on the group difference [Infanrix-Hib + Poliorix Group minus Infanrix-IPV+Hib 1 Group] in percentage of seroprotected subjects ≤ 10%. |
| Anti-D, M3/M4 |
|
|
| Anti-T, M0 |
|
|
| Anti-T, M3/M4 |
|
|
| Anti-PRP, M3/M4 |
|
|
| Anti-polio 1, M3/M4 |
|
|
| Anti-polio 2, M0 |
|
|
| Anti-polio 2, M3/M4 |
|
|
| Anti-polio 3, M0 |
|
|
| Anti-polio 3, M3/M4 |
|
|
| Anti-PT, M3/M4 |
|
|
| Anti-FHA, M0 |
|
|
| Anti-FHA, M3/M4 |
|
|
| Anti-PRN, M0 |
|
|
| Anti-PRN, M3/M4 |
|
|
| Any Redness, Dose 1 |
|
|
| Any Swelling, Dose 1 |
|
|
| Any Pain, Dose 2 |
|
|
| Any Redness, Dose 2 |
|
|
| Any Swelling, Dose 2 |
|
|
| Any Pain, Dose 3 |
|
|
| Any Redness, Dose 3 |
|
|
| Any Swelling, Dose 3 |
|
|
| Any Pain, Across doses |
|
|
| Any Redness, Across doses |
|
|
| Any Swelling, Across doses |
|
|
| Any Irritability, Dose 1 |
|
|
| Any Loss of appetite, Dose 1 |
|
|
| Any Fever/Axillary, Dose 1 |
|
|
| Any Drowsiness, Dose 2 |
|
|
| Any Irritability, Dose 2 |
|
|
| Any Loss of appetite, Dose 2 |
|
|
| Any Fever/Axillary, Dose 2 |
|
|
| Any Drowsiness, Dose 3 |
|
|
| Any Irritability, Dose 3 |
|
|
| Any Loss of appetite, Dose 3 |
|
|
| Any Fever/Axillary, Dose 3 |
|
|
| Any Drowsiness, Across doses |
|
|
| Any Irritability, Across doses |
|
|
| Any Loss of appetite, Across doses |
|
|
| Any Fever/Axillary, Across doses |
|
|