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| ID | Type | Description | Link |
|---|---|---|---|
| V72_60 | Other Identifier | Novartis | |
| 2014-005568-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when concomitantly administered with routine vaccines in healthy infants in Taiwan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bexsero + Routine Group | Experimental | Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age. |
|
| Routine Group | Active Comparator | Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bexsero® | Biological | Four doses administered in the anterolateral area of the right or left thigh. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains | Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®). | At Day 1 and at one month after the third vaccination (Day 152) |
| Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains | Percentage of subjects with hSBA titer ≥ 1:4 at 1 month after third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®). | At Day 1 and at one month after third vaccination (Day 152) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) | Percentage of subjects with hSBA titer ≥ 1:5 before booster vaccination and after booster vaccination when Bexsero® booster dose was given with routine vaccines (Priorix® + Varilrix® vaccine) as compared to when only routine vaccines were administered. |
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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 | Taipei | 10041 | Taiwan | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29337653 | Background | Chiu NC, Huang LM, Willemsen A, Bhusal C, Arora AK, Reynoso Mojares Z, Toneatto D. Safety and immunogenicity of a meningococcal B recombinant vaccine when administered with routine vaccines to healthy infants in Taiwan: A phase 3, open-label, randomized study. Hum Vaccin Immunother. 2018 May 4;14(5):1075-1083. doi: 10.1080/21645515.2018.1425659. Epub 2018 Feb 15. |
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
All subjects were enrolled
Subjects were recruited from 2 sites in Taiwan
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| ID | Title | Description |
|---|---|---|
| FG000 | Bexsero + Routine Group | Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Routine vaccines | Biological | Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh. |
|
| At Day 305 and Day 335 |
| hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines | hSBA GMTs against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 was evaluated at baseline (2 months of age, Day 1), 1 month after the third vaccination with Bexsero® with concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13®, Engerix®) (7 months of age, Day 152) or prior to the booster dose of Bexsero® with routine vaccines (Priorix®, Varilrix®) (12 months of age, Day 305) and 1 month after the booster dose (13 months of age, Day 335), as compared to when only routine vaccines were administered. | At Day 1, Day 152, Day 305 and Day 335 |
| hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. | GMRs of post-vaccination versus pre-vaccination of hSBA titer against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 were evaluated at one month after the third vaccination with Bexsero® vaccine and concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13® and Engerix®) (Day 152) compared to baseline (Day 1) or at one month after the booster dose of Bexsero® vaccine with routine vaccines (Priorix®, Varilrix®) (Day 335) compared to prior to the booster dose (Day 305). | At Day 1, Day 152, Day 305 and Day 335 |
| Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines | Percentages of subjects with hSBA titers ≥1:8 against N.meningitidis serogroup B strains, at one month after concomitant administration of third primary dose of Bexsero® with routine vaccines [Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®] and at one month after concomitant administration of Bexsero® booster dose with routine vaccines [Priorix® and Varilrix® vaccine],as compared to when only routine vaccines were administered. | At Day 1,Day 152,Day 305, Day 335 |
| Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. | Number of subjects reporting solicited local AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age)compared to when only routine vaccines were administered alone at 2,4,6 and 12 months. Solicited local symptoms assessed were Erythema, Induration, Swelling and Tenderness. | From day 1 (6 hours) to day 7 after each vaccination (1st, 2nd, 3rd and 4th vaccination) |
| Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. | Number of subjects reporting solicited systemic AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age) compared to when only routine vaccines were alone, at 2, 4, 6 and 12 months. Systemic solicited symptoms assessed were Change in Eating Habits, Diarrhea, Irritability, Persistent Crying, Rash, Sleepiness, Vomiting and Fever (body temperature ≥ 38.0 °C) | From day 1 (6 hours) to day 7 after each vaccination |
| Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age. | Number of subjects who reported solicited systemic AEs reported after the administration of Varilrix® and Priorix® vaccines (with and without Bexsero® vaccine) at 12 months of age. Solicited systemic AEs assessed were Rash, Lymphadenopathy and Fever. This analysis was conducted for a prolonged period of 28 Days following Varilrix® and Priorix® administration. | From Day 1 to Day 28 after vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines | Number of subjects reporting any unsolicited AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B® or Priorix® and Varilrix®) compared to when only routine vaccines were administered alone. | From day 1 to day 7 after each vaccination |
| Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization. | Number of subjects reporting SAEs, medically attended AEs and AEs leading to premature withdrawal from the study and leading to death and AEs leading to hospitalization following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix®) compared to when only routine vaccines were administered alone. SAEs assessed included medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Possibly or probably related SAE were SAEs assessed by the investigator as related to the vaccination. Medically attended AEs were events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. | Throughout the study period (Day 1 to Day 335) |
| Taipei |
| 10449 |
| Taiwan |
| FG001 |
| Routine Group |
Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bexsero + Routine Group | Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age. |
| BG001 | Routine Group | Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Days |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Subjects With Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B Strains | Percentage of subjects with hSBA titer ≥ 1:5 at 1 month following the third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®). | Analysis was done on Full Analysis Population (FAS) population day 152, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points. | Posted | Number | 95% Confidence Interval | Percentages of subjects | At Day 1 and at one month after the third vaccination (Day 152) |
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| Primary | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 1:4 Against Neisseria Meningitidis Serogroup B Strains | Percentage of subjects with hSBA titer ≥ 1:4 at 1 month after third vaccination (at 7 months of age) against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 when Bexsero® was given concomitantly with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®). | Analysis was done on Full Analysis Set (FAS) population day 152. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 1 and at one month after third vaccination (Day 152) |
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| Secondary | Percentage of Subjects With hSBA Titer ≥ 1:5 Against Neisseria Meningitidis Serogroup B, When Bexsero® Booster Was Given With Routine Vaccines (Priorix® + Varilrix® Vaccines) | Percentage of subjects with hSBA titer ≥ 1:5 before booster vaccination and after booster vaccination when Bexsero® booster dose was given with routine vaccines (Priorix® + Varilrix® vaccine) as compared to when only routine vaccines were administered. | Analysis was done on FAS population Day 335. The FAS population included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points. | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 305 and Day 335 |
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| Secondary | hSBA Geometric Mean Titers (GMTs) Against Neisseria Meningitidis Serogroup B Indicator Strains, When Bexsero® Vaccine Was Given With Routine Vaccines | hSBA GMTs against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 was evaluated at baseline (2 months of age, Day 1), 1 month after the third vaccination with Bexsero® with concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13®, Engerix®) (7 months of age, Day 152) or prior to the booster dose of Bexsero® with routine vaccines (Priorix®, Varilrix®) (12 months of age, Day 305) and 1 month after the booster dose (13 months of age, Day 335), as compared to when only routine vaccines were administered. | Analysis was performed on the FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Day 1, Day 152, Day 305 and Day 335 |
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| Secondary | hSBA Geometric Mean Ratios (GMRs) Against Neisseria Meningitidis Serogroup B Strains. | GMRs of post-vaccination versus pre-vaccination of hSBA titer against the indicator strains H44/76, 5/99, NZ98/254 and strain M10713 were evaluated at one month after the third vaccination with Bexsero® vaccine and concomitant routine vaccines (Infanrix-IPV+Hib®, Prevenar-13® and Engerix®) (Day 152) compared to baseline (Day 1) or at one month after the booster dose of Bexsero® vaccine with routine vaccines (Priorix®, Varilrix®) (Day 335) compared to prior to the booster dose (Day 305). | Analysis was performed on the FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 1, Day 152, Day 305 and Day 335 |
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| Secondary | Percentages of Subjects With hSBA Titers ≥1:8 Against Neisseria Meningitidis Serogroup B, When Bexsero® Vaccine Was Given With Routine Vaccines | Percentages of subjects with hSBA titers ≥1:8 against N.meningitidis serogroup B strains, at one month after concomitant administration of third primary dose of Bexsero® with routine vaccines [Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B®] and at one month after concomitant administration of Bexsero® booster dose with routine vaccines [Priorix® and Varilrix® vaccine],as compared to when only routine vaccines were administered. | Analysis was done on FAS population, which included all subjects in the exposed set who received at least one dose of a study vaccination and provided immunogenicity data at relevant time points. | Posted | Number | 95% Confidence Interval | Percentages of subjects | At Day 1,Day 152,Day 305, Day 335 |
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| Secondary | Number of Subjects Reporting Solicited Local Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. | Number of subjects reporting solicited local AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age)compared to when only routine vaccines were administered alone at 2,4,6 and 12 months. Solicited local symptoms assessed were Erythema, Induration, Swelling and Tenderness. | Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data. | Posted | Number | Number of participants | From day 1 (6 hours) to day 7 after each vaccination (1st, 2nd, 3rd and 4th vaccination) |
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| Secondary | Number of Subjects Reporting Solicited Systemic Adverse Events (AEs) After Receiving Bexsero® Vaccine With Routine Vaccine or Routine Vaccines Alone, at 2, 4, 6 and 12 Months of Age. | Number of subjects reporting solicited systemic AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13® and Engerix-B® at 2, 4 and 6 months of age and Priorix® and Varilrix® at 12 months of age) compared to when only routine vaccines were alone, at 2, 4, 6 and 12 months. Systemic solicited symptoms assessed were Change in Eating Habits, Diarrhea, Irritability, Persistent Crying, Rash, Sleepiness, Vomiting and Fever (body temperature ≥ 38.0 °C) | Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data. | Posted | Number | Number of participants | From day 1 (6 hours) to day 7 after each vaccination |
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| Secondary | Number of Subjects Reporting Solicited Systemic AEs After Receiving Priorix® and Varilrix® Routine Vaccines (With and Without Bexsero® Vaccine) at 12 Months of Age. | Number of subjects who reported solicited systemic AEs reported after the administration of Varilrix® and Priorix® vaccines (with and without Bexsero® vaccine) at 12 months of age. Solicited systemic AEs assessed were Rash, Lymphadenopathy and Fever. This analysis was conducted for a prolonged period of 28 Days following Varilrix® and Priorix® administration. | Analysis was done on Safety set population (solicited AEs).The safety set population (solicited AEs) included all subjects in the Exposed Population who provided postvaccination reactogenicity data. | Posted | Number | Number of participants | From Day 1 to Day 28 after vaccination |
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| Secondary | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Bexsero® Vaccination With Routine Vaccines | Number of subjects reporting any unsolicited AEs following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B® or Priorix® and Varilrix®) compared to when only routine vaccines were administered alone. | Analysis was done on Safety set population (unsolicited AEs). The safety set population (unsolicited AEs) included all subjects in the Exposed Population who had postvaccination unsolicited AE records. | Posted | Number | Number of subjects | From day 1 to day 7 after each vaccination |
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| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs), Medically Attended AEs (MAEs) and AEs Leading to Premature Withdrawal and Death and AEs Leading to Hospitalization. | Number of subjects reporting SAEs, medically attended AEs and AEs leading to premature withdrawal from the study and leading to death and AEs leading to hospitalization following concomitant administration of Bexsero® vaccine with routine vaccines (Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix®) compared to when only routine vaccines were administered alone. SAEs assessed included medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Possibly or probably related SAE were SAEs assessed by the investigator as related to the vaccination. Medically attended AEs were events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. | Analysis was done on Safety set population (unsolicited AEs). The safety set population (unsolicited AEs) included all subjects in the Exposed Population who had postvaccination unsolicited AE records. | Posted | Number | Number of participants | Throughout the study period (Day 1 to Day 335) |
|
Solicited local AEs and systemic symptoms: from Day 1 to Day 7 after each vaccination; Unsolicited AEs and SAEs: throughout the study period (from Day 1 to Day 335).
Serious adverse events were analysed based on the unsolicited safety set and other adverse events were analysed based on the overall safety set. Therefore, the number of participants at risk in the serious adverse events are lesser compared to the number of participants at risk in the other adverse events.
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 | Bexsero + Routine Group | Subjects received three doses of Bexsero® vaccine at 2, 4, 6 months followed by a booster dose at 12 months, concomitantly administered with routine vaccines (i.e. combined Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® at 6 months of age; Priorix® and Varilrix® at 12 months of age. | 0 | 148 | 13 | 145 | 148 | 148 |
| EG001 | Routine Group | Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age. | 0 | 73 | 8 | 72 | 72 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kawasaki's disease | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Crying | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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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 |
|---|---|
| D008589 | Meningococcal Infections |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C570015 | 4CMenB vaccine |
Not provided
Not provided
Not provided
| Male |
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| H44/76 strain [Day 152] |
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| 5/99 strain [Day 1] |
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| 5/99 strain [Day 152] |
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| M10713 strain [Day 1] |
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| M10713 strain [Day 152] |
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| NZ98/254 strain [Day 1] |
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| NZ98/254 strain [Day 152] |
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| Statistical analysis NZ98/254 strain: The power to reject the null hypothesis associated with the primary objective for strain NZ98/25 was 94%. | Exact test of binomial proportion | single binomial proportion | 79 | 2-Sided | 95 | 71.4 | 85.8 | Non-Inferiority or Equivalence (legacy) | Sufficiency: The criterion for a sufficient immune response was that the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA titer ≥ 1:5 should be ≥ 70%. |
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| Units | Counts |
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| Participants |
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| Units |
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| Participants |
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| OG001 | Routine Group | Subjects received routine vaccines Infanrix-IPV + Hib® and Prevenar-13® at 2, 4, 6 months of age; Engerix-B® vaccine at 6 months; Priorix® and Varilrix® vaccines at 12 months of age. |
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