Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 105245 | Other Identifier | GSK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC.
Blood samples will be drawn from subjects as follows:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP | Experimental | Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
|
| TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP | Active Comparator | Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tritanrix™- HepB | Biological | One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies | Antibody cut-offs were higher than or equal to (≥) 1:128 | 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128 | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. |
| Anti-rSBA-MenA, C Antibody Titers |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Manila | 1000 | Philippines | |||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 105239 (mth24-30) | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Subjects previously primed with 3 doses of Tritanrix-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| FG001 | Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Subjects previously primed with 3 doses Tritanrix-HepB/Hiberix vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Subjects previously primed with 3 doses of Tritanrix-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| 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 Subjects With Serum Bactericidal Activity Against Neisseria Meningitidis Serogroups A, C (rSBA-MenA, C) Using Rabbit Complement Antibodies | Antibody cut-offs were higher than or equal to (≥) 1:128 | The analyses were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age). |
|
SAE(s): From Day 0 at Months 15-24 of age and up to study end at Months 25-31 of age. Solicited local/general symptoms: During the 4-day follow-up period after vaccination.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group | Subjects previously primed with 3 doses of Tritanrix-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D006509 | Hepatitis B |
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C514867 | Hiberix |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hiberix™ | Biological | One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months |
|
| Mencevax™ ACWY | Biological | One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months |
|
Antibody titers were expressed as Geometric Mean Titers (GMTs) |
| Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. |
| Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL). | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. |
| Anti-PSA, Anti-PSC Antibody Concentrations | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs). | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. |
| Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs | The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL). | Prior to the Mencevax ACWY vaccination at 24-30 Months of age |
| Anti-HBs Concentrations | Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs). | Prior to the Mencevax ACWY vaccination at 24-30 Months of age |
| Number of Subjects With Vaccine Response for rSBA-Men A, C | Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer < 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA > 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination. | 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age). |
| Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade. | During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever [≥ 38 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade. | During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age |
| 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 is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination. | From Day 0 at months 15-24 of age to study end at Months 25-31 of age |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | From 15-24 Months of age up to Months 25-31 of age |
| Sampaloc, Manila |
| 1008 |
| Philippines |
For additional information about this study please refer to the GSK Clinical Study Register |
| 105239 (mth24-30) | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105239 (mth24-30) | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105239 (mth24-30) | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105239 (mth24-30) | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 105239 are summarised with study 105245 on the GSK Clinical Study Register. |
| 105239 (mth24-30) | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| BG001 | Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Subjects previously primed with 3 doses Tritanrix-HepB/Hiberix vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Subjects previously primed with 3 doses Tritanrix-HepB/Hiberix vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
|
|
| Secondary | Number of Subjects With Anti-rSBA-MenA, C Antibody Titers ≥ Pre-defined Cut-off Values | Pre-defined cut-offs were ≥ 1:8 and ≥ 1:128 | The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. |
|
|
|
| Secondary | Anti-rSBA-MenA, C Antibody Titers | Antibody titers were expressed as Geometric Mean Titers (GMTs) | The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. |
|
|
|
| Secondary | Number of Subjects With Anti-pilysaccharide A and C (Anti-PSA/PSC) Antibody Concentrations ≥ Predefined Cut-off Values | Antibody cut-offs were ≥ 0.3, 2 micrograms per millilitre (µg/mL). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. |
|
|
|
| Secondary | Anti-PSA, Anti-PSC Antibody Concentrations | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Prior to (at 24 to 30 months of age) and after (at 25 to 31 months of age) Mencevax ACWY vaccination. |
|
|
|
| Secondary | Number of Subjects With Anti-hepatitis B Surface (Anti-HBs) Antigen Antibody Concentrations ≥ Cut-offs | The antibody concentrations cut-off was ≥ 10 milli international units per millilitre (mIU/mL). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | Prior to the Mencevax ACWY vaccination at 24-30 Months of age |
|
|
|
| Secondary | Anti-HBs Concentrations | Antibody concnetrations were expressed as Geometric Mean Concentrations (GMCs). | The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Prior to the Mencevax ACWY vaccination at 24-30 Months of age |
|
|
|
| Secondary | Number of Subjects With Vaccine Response for rSBA-Men A, C | Vaccine response was defined as follows: for initially seronegative subjects (i.e. with rSBA titer < 1:8 pre-vaccination), rSBA titer ≥ 1:32 post-vaccination (seroconversion), and for initially seropositive subjects (i.e. with rSBA > 1:8 prevaccination), at least a 4-fold increase in rSBA titer from pre-vaccination to post-vaccination. | The analysis were performed on the Booster ATP cohort for immunogenicity which included all subjects who had received 3 doses in the primary vaccination study, who had received a single dose of MenACWY according to protocol at 24 to 30 months of age and for whom data concerning immunogenicity measures were available. | Posted | Number | Subjects | 1 month after Mencevax ACWY vaccination (at 25 to 31 months of age). |
|
|
|
| Secondary | Number of Subjects With Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness, swelling. Any = symptom occurring regardless of intensity grade. | The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343. | Posted | Number | Subjects | During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age |
|
|
|
| Secondary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, rectal fever [≥ 38 degrees Celsius (°C)]. Any = occurrence of symptom regardless of intensity grade. | The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343. | Posted | Number | Subjects | During the 4-day follow-up period after the Mencevax ACWY vaccination, at 24-30 months of age |
|
|
|
| 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 is defined as the occurrence of any unsolicited AE regard-less of intensity grade or relation to vaccination. | The analysis were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343. | Posted | Number | Subjects | From Day 0 at months 15-24 of age to study end at Months 25-31 of age |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | 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 were performed on the Booster Total Vaccinated Cohort included all subjects vaccinated during study NCT00291343. | Posted | Number | Subjects | From 15-24 Months of age up to Months 25-31 of age |
|
|
|
| 6 |
| 203 |
| 125 |
| 203 |
| EG001 | Tritanrix-HepB/Hiberix+Mencevax ACWY Group | Subjects previously primed with 3 doses Tritanrix-HepB/Hiberix vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix-HepB/Hiberix, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. | 1 | 93 | 59 | 93 |
| Diarrhoea infectious | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Food intolerance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Amoebiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Ascariasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Redness | General disorders | MedDRA | Systematic Assessment |
|
| Swelling | General disorders | MedDRA | Systematic Assessment |
|
| DROWSINESS | General disorders | MedDRA | Systematic Assessment |
|
| IRRITABILITY | General disorders | MedDRA | Systematic Assessment |
|
| LOSS OF APPETITE | General disorders | MedDRA | Systematic Assessment |
|
| FEVER | General disorders | MedDRA | 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 |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001885 | Bordetella Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D016871 | Pasteurellaceae Infections |
| rSBA-MenA ≥1:8 (M25-31) |
|
|
| rSBA-MenA ≥1:128 (M24-30) |
|
|
| rSBA-MenC ≥1:8 (M24-30) |
|
|
| rSBA-MenC ≥1:8 (M25-31) |
|
|
| rSBA-MenC ≥1:128 (M24-30) |
|
|
| rSBA-MenA (M25-31) |
|
|
| rSBA-MenC (M24-30) |
|
|
| rSBA-MenC (M25-31) |
|
|
| anti-PSA ≥ 0.3 µg/mL (M25-31) |
|
|
| anti-PSA ≥ 2 µg/mL (M24-30) |
|
|
| anti-PSA ≥ 2 µg/mL (M25-31) |
|
|
| anti-PSC ≥ 0.3 µg/mL (M24-30) |
|
|
| anti-PSC ≥ 0.3 µg/mL (M25-31) |
|
|
| anti-PSC ≥ 2 µg/mL (M24-30) |
|
|
| anti-PSC ≥ 2 µg/mL (M25-31) |
|
|
| anti-PSA (M25-31) |
|
|
| anti-PSC (M24-30) |
|
|
| anti-PSC (M25-31) |
|
|
| rSBA-MenC, Total |
|
|
| Any Swelling |
|
| Any Loss of appetite |
|
| Any fever (rectal) |
|