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| ID | Type | Description | Link |
|---|---|---|---|
| 104171 | Other Identifier | GSK |
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This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepB/Hib-MenAC. No blood samples will be taken in this safety study.
Subjects previously primed with Tritanrix-HepB/Hib-MenAC will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m), respectively, without or with Mencevax ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix-HepB/Hiberix will receive Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hiberix vaccine (at 15-18/24 m) with Mencevax ACWY vaccine at 24 to 30 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACAC_Thailand Group | Experimental | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study ( NCT00317187) are boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
|
| ACHibPS_Thailand Group | Experimental | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
|
| HibACPS_Thailand Group | Experimental | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tritanrix-HepB/Hib-MenAC | Biological | Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Fever >39°C (Rectal Route). | Among solicited general symptoms fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )] was assessed, post vaccination. Grade 3 fever = fever > 39.0 °C. | During the 4-day (Day 0-3) follow-up period after booster vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | City of Muntinlupa | 1781 | 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 |
|---|---|---|---|
| 103812 | Statistical Analysis Plan | 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACAC_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| HibHibPS_Thailand Group |
| Experimental |
Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
|
| ACAC_Philippines Group | Experimental | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
|
| ACHibPS_Philippines Group | Experimental | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
|
| HibACPS_Philippines Group | Experimental | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
|
| HibHibPS_Philippines Group | Experimental | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
|
| Tritanrix-HepB/Hiberix | Biological | Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine |
|
| Mencevax-ACWY | Biological | Meningococcal Serogroups A, C, W-135 and Y Vaccine |
|
| During the 4-day (Day 0-3) follow-up period after vaccination |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | During the 4-day (Day 0-3) follow-up period after booster vaccination |
| Number of Subjects With Any 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 (Day 0-30) following booster vaccination |
| 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. | From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination |
| Bangkok |
| 10400 |
| Thailand |
For additional information about this study please refer to the GSK Clinical Study Register |
| 103812 | 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 103812 are summarised with study 104727 on the GSK Clinical Study Register. |
| 103812 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103812 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103812 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 103812 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | ACHibPS_Thailand Group | Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| FG002 | HibACPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| FG003 | HibHibPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| FG004 | ACAC_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| FG005 | ACHibPS_Philippines Group | Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| FG006 | HibACPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| FG007 | HibHibPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
[Not Specified]
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ACAC_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix-HepB co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| BG001 | ACHibPS_Thailand Group | Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| BG002 | HibACPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| BG003 | HibHibPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| BG004 | ACAC_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| BG005 | ACHibPS_Philippines Group | Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| BG006 | HibACPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| BG007 | HibHibPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Fever >39°C (Rectal Route). | Among solicited general symptoms fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )] was assessed, post vaccination. Grade 3 fever = fever > 39.0 °C. | This analysis was performed on Booster Total Vaccinated cohort which included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets. | Posted | Count of Participants | Participants | During the 4-day (Day 0-3) follow-up period after booster vaccination |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination. | This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets. | Posted | Count of Participants | Participants | During the 4-day (Day 0-3) follow-up period after vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms. | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets. | Posted | Number | Subjects | During the 4-day (Day 0-3) follow-up period after booster vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Any 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. | This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets. | Posted | Number | Subjects | During the 31-day (Day 0-30) following booster vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | This analysis was performed on the Booster Total Vaccinated cohort included all subjects who have received three doses according to protocol in the primary vaccination course (primary vaccination studies) and who have received the booster vaccine dose according to protocol,only taking into account those subjects who returned their symptom sheets. | Posted | Number | Subjects | From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination |
|
Solicited local and general symptoms during the 4-day(Day 0-3)follow-up period after vaccination. Unsolicited AEs during the 31-day(Day 0-30)follow-up period after vaccination.SAEs from 15 to 18 months/15 to 24 months of age and up to 25 to 31 months of age(i.e a duration of Minimum of 6 months and a maximum of 16 months per subject(depending on the study group,on the recommended national vaccination schedule and on how the study will be organized at the different centers by the investigators)
Detailed analysis (i.e solicited and unsolicited merge analysis for other adverse event section as well as medical coding for this adverse event section) was only performed on the pooled groups
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 | ACAC Group | Subjects from both ACAC_Thailand and ACAC_Philippines groups | 0 | 398 | 5 | 398 | 376 | 398 |
| EG001 | ACHibPS Group | Subjects from both ACHibPS_Thailand and ACHibPS_Philippines groups | 0 | 200 | 1 | 200 | 181 | 200 |
| EG002 | HibACPS Group | Subjects from both HibACPS_Thailand and HibACPS_Philippines groups | 0 | 134 | 0 | 134 | 129 | 134 |
| EG003 | HibHibPS Group | Subjects from both HibHibPS _Thailand and HibHibPS _Philippines groups | 0 | 66 | 0 | 66 | 60 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MeDRA | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MeDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D013742 | Tetanus |
| D006509 | Hepatitis B |
| D004165 | Diphtheria |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| 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 |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000610192 | PsACWY vaccine |
Not provided
Not provided
Not provided
| Male |
|
| OG002 | HibACPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| OG003 | HibHibPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG004 | ACAC_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| OG005 | ACHibPS_Philippines Group | Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG006 | HibACPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG007 | HibHibPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
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| OG002 | HibACPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| OG003 | HibHibPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG004 | ACAC_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| OG005 | ACHibPS_Philippines Group | Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG006 | HibACPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG007 | HibHibPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
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Subjects vaccinated with 3 doses of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Tritanrix HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm
| OG002 | HibACPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| OG003 | HibHibPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG004 | ACAC_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| OG005 | ACHibPS_Philippines Group | Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG006 | HibACPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG007 | HibHibPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
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| OG002 | HibACPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of Trianrix-HepB coadministrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| OG003 | HibHibPS_Thailand Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG004 | ACAC_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB coadministrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| OG005 | ACHibPS_Philippines Group | Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG006 | HibACPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| OG007 | HibHibPS_Philippines Group | Subjects vaccinated with 3 doses of Tritanrix HepB/Hiberix vaccine in the primary study (NCT00317135) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
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