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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Open Label, Parallel Assignment |
| Condition: |
Hepatitis A |
| Interventions: |
Biological: Havrix™ Biological: Infanrix™ Biological: ActHIB™ |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Of the total of 468 subjects enrolled, only 394 were vaccinated and as such considered as 'started'. |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
| STARTED | 135 | 127 | 132 |
| COMPLETED | 121 | 110 | 109 |
| NOT COMPLETED | 14 | 17 | 23 |
| Adverse Event | 1 | 0 | 1 |
| Lost to Follow-up | 5 | 14 | 6 |
| Protocol Violation | 0 | 0 | 1 |
| Withdrawal by Subject | 7 | 3 | 11 |
| Study drug/medication expiration | 1 | 0 | 3 |
| Returned out of specified time window | 0 | 0 | 1 |
Baseline Characteristics
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | Total | |
|---|---|---|---|---|
|
Number of Participants [units: participants] |
135 | 127 | 132 | 394 |
|
Age [units: months] Mean ± Standard Deviation |
15.1 ± 0.36 | 15.1 ± 0.3 | 15.0 ± 0.21 | 15.1 ± 0.30 |
|
Gender [units: subjects] |
||||
| Female | 55 | 64 | 67 | 186 |
| Male | 80 | 63 | 65 | 208 |
Outcome Measures
| 1. Primary: | Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix [ 31 days following the second dose of Havrix™ ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix |
| Measure Description | Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL). |
| Time Frame | 31 days following the second dose of Havrix™ |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity including subjects who had at least one study vaccine administered and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
88 | 84 | 77 |
|
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix
[units: subjects] |
88 | 84 | 77 |
| 2. Primary: | Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects [ 31 days following the administration of Infanrix™ and ActHIB ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects |
| Measure Description | Subjects are defined as being anti-diphtheria, anti-tetanus and anti-PRP seroprotected if their anti-diphtheria and anti-tetanus antibody concentration is ≥ 0.1 International Units per milliliter (IU/mL) and if their anti-PRP antibody concentration is ≥ 1 microgram per milliliter (μg/mL), respectively. |
| Time Frame | 31 days following the administration of Infanrix™ and ActHIB |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines. |
| Description | |
|---|---|
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
90 | 80 | 0 |
|
Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects
[units: subjects] |
|||
| Anti-diphtheria (n=89, 80) | 89 | 80 | |
| Anti-tetanus (n=88, 80) | 88 | 80 | |
| Anti-PRP (n=90, 79) | 90 | 77 |
| 3. Primary: | Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN) [ 31 days following the administration of Infanrix™ and ActHIB ] |
| Measure Type | Primary |
|---|---|
| Measure Title | Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN) |
| Measure Description | Subjects are considered as being vaccine responders if they were initially seronegative and become seropositive (≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL)), or were initially seropositive and have a 2-fold increase above pre-study concentrations. |
| Time Frame | 31 days following the administration of Infanrix™ and ActHIB |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines. |
| Description | |
|---|---|
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
88 | 76 | 0 |
|
Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)
[units: subjects] |
|||
| Anti-PT (n=88,74) | 87 | 71 | |
| Anti-FHA (n=88,76) | 85 | 75 | |
| Anti-PRN (n=88,75) | 86 | 74 |
| 4. Secondary: | Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC) [ 31 days following the administration of Infanrix™ and ActHIB ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC) |
| Measure Description | GMCs are expressed as International Units per milliliter (IU/mL). |
| Time Frame | 31 days following the administration of Infanrix™ and ActHIB |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines. |
| Description | |
|---|---|
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
89 | 80 | 0 |
|
Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)
[units: IU/mL] Geometric Mean ( 95% Confidence Interval ) |
|||
| Anti-diphtheria (n= 89, 80) | 11.3 ( 9.8 to 13.1 ) |
10.3 ( 8.7 to 12.3 ) |
|
| Anti-tetanus (n= 88, 80) | 7.0 ( 5.9 to 8.2 ) |
7.3 ( 6.0 to 8.8 ) |
| 5. Secondary: | Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC) [ 31 days following the administration of Infanrix™ and ActHIB ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC) |
| Measure Description | GMCs are expressed as microgram/milliliter (µg/mL). |
| Time Frame | 31 days following the administration of Infanrix™ and ActHIB |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines. |
| Description | |
|---|---|
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
90 | 79 | 0 |
|
Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)
[units: µg/mL] Geometric Mean ( 95% Confidence Interval ) |
60.8 ( 45.9 to 80.4 ) |
41.0 ( 30.0 to 55.9 ) |
| 6. Secondary: | Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP) [ 31 days following the administration of Infanrix™ and ActHIB ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP) |
| Measure Description | Seropositivity is defined as antibody concentrations ≥ 5 Enzyme Linked Immunosorbent Assay Units per Milliliter (EL.U/mL) for anti-PT, anti-FHA and anti-PRN antibodies and as antibody concentrations ≥ 0.15 microgram/milliliter (µg/mL) for anti-PRP antibodies. |
| Time Frame | 31 days following the administration of Infanrix™ and ActHIB |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for those groups receiving Infanrix and ActHIB vaccines. |
| Description | |
|---|---|
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
90 | 79 | 0 |
|
Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)
[units: subjects] |
|||
| Anti-PT (n= 89, 80) | 89 | 80 | |
| Anti-FHA (n= 89, 80) | 89 | 80 | |
| Anti-PRN (n= 89, 80) | 89 | 80 | |
| Anti-PRP (n= 90, 79) | 90 | 79 |
| 7. Secondary: | Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix [ 31 days following the first dose of Havrix™ ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix |
| Measure Description | Subjects are defined as being anti-HAV seropositive if their anti-HAV antibody concentration is ≥ 15 milli-International Units per milliliter (mIU/mL). |
| Time Frame | 31 days following the first dose of Havrix™ |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group. |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
94 | 89 | 0 |
|
Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix
[units: subjects] |
82 | 77 |
| 8. Secondary: | Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix [ 31 days following the first dose of Havrix™ ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix |
| Measure Description | Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL). |
| Time Frame | 31 days following the first dose of Havrix™ |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity, only for the Havrix Group and the Havrix + Infanrix + ActHIB Group. |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
94 | 89 | 0 |
|
Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix
[units: mIU/mL] Geometric Mean ( 95% Confidence Interval ) |
51.5 ( 41.7 to 63.7 ) |
51.5 ( 41.8 to 63.5 ) |
| 9. Secondary: | Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix [ 31 days following the second dose of Havrix™ ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix |
| Measure Description | Anti-hepatitis A (HAV) antibody geometric mean concentrations (GMC) are expressed as milli-International Units per milliliter (mIU/mL). |
| Time Frame | 31 days following the second dose of Havrix™ |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity. |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
88 | 84 | 77 |
|
Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix
[units: mIU/mL] Geometric Mean ( 95% Confidence Interval ) |
1700.4 ( 1306.0 to 2213.7 ) |
1904.4 ( 1552.7 to 2335.7 ) |
1625.1 ( 1378.2 to 1916.3 ) |
| 10. Secondary: | Number of Subjects With Vaccine Response to Havrix™. [ 31 days following the second dose ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects With Vaccine Response to Havrix™. |
| Measure Description | Vaccine response to Havrix is defined as post-vaccination anti-HAV antibody concentrations ≥ 15 mIU/mL in initially seronegative subjects or a ≥ 2-fold increase above the pre-vaccination anti-HAV antibody concentration in initially seropositive subjects. |
| Time Frame | 31 days following the second dose |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| Analysis was performed on the According-to-Protocol cohort for immunogenicity |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
86 | 83 | 74 |
|
Number of Subjects With Vaccine Response to Havrix™.
[units: subjects] |
86 | 83 | 74 |
| 11. Secondary: | Number of Subjects Reporting Solicited Local Adverse Events (AEs) [ 4-day period following each dose of study vaccine(s) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Reporting Solicited Local Adverse Events (AEs) |
| Measure Description | Solicited local AEs assessed include pain, redness and swelling. Data across doses are presented in the table. |
| Time Frame | 4-day period following each dose of study vaccine(s) |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
130 | 118 | 122 |
|
Number of Subjects Reporting Solicited Local Adverse Events (AEs)
[units: subjects] |
|||
| Pain | 44 | 60 | 70 |
| Redness | 34 | 54 | 63 |
| Swelling | 21 | 38 | 46 |
| 12. Secondary: | Number of Subjects Reporting Solicited General Adverse Events (AEs) [ 4-day period following each dose of study vaccine(s) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Reporting Solicited General Adverse Events (AEs) |
| Measure Description | Solicited general AEs assessed include drowsiness, axillary fever ≥ 37.5°C, irritability and loss of appetite. Data across doses are presented in the table. |
| Time Frame | 4-day period following each dose of study vaccine(s) |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
130 | 118 | 123 |
|
Number of Subjects Reporting Solicited General Adverse Events (AEs)
[units: subjects] |
|||
| Drowsiness | 44 | 50 | 53 |
| Fever | 16 | 26 | 31 |
| Irritability | 56 | 62 | 70 |
| Loss of appetite | 33 | 40 | 48 |
| 13. Secondary: | Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ 31-day period following each dose of study vaccine(s) ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Reporting Unsolicited Adverse Events (AEs) |
| Measure Description | An Adverse Event is 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. |
| Time Frame | 31-day period following each dose of study vaccine(s) |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analysis was performed on the Total Vaccinated Cohort |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
135 | 127 | 132 |
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
[units: subjects] |
75 | 69 | 71 |
| 14. Secondary: | Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events [ Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase. ] |
| Measure Type | Secondary |
|---|---|
| Measure Title | Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events |
| Measure Description | Since the related information about medically significant events was not specifically collected and new chronic illnesses were only collected in the extended safety follow-up phase, all unsolicited adverse events (AEs) throughout the study are reported in the table without identifying which event was a medically significant or new chronic illness. |
| Time Frame | Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase. |
| Safety Issue | No |
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| The analyses were performed on the Total Vaccinated Cohort for the active phase of the study and on the Extended safety follow-up cohort for the 6-month extended follow-up (ESFU) phase. |
| Description | |
|---|---|
| Havrix Group | Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Havrix + Infanrix + ActHIB Group | Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9. |
| Infanrix + ActHIB→Havrix Group | Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10. |
| Havrix Group | Havrix + Infanrix + ActHIB Group | Infanrix + ActHIB→Havrix Group | |
|---|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
135 | 127 | 132 |
|
Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events
[units: subjects] |
|||
| SAEs (n= 135, 127, 132) | 5 | 2 | 4 |
| AEs during Active Phase (n= 135, 127, 132) | 80 | 74 | 72 |
| AEs during ESFU (n=119,111,109) | 11 | 10 | 7 |
More Information
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 208109/232 |
| Study First Received: | September 15, 2005 |
| Results First Received: | December 2, 2008 |
| Last Updated: | July 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00197236 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
