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| ID | Type | Description | Link |
|---|---|---|---|
| V72_56 | Other Identifier | Novartis | |
| 2016-005117-44 | EudraCT Number |
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The purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rMenB+ACWY | Experimental | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
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| rMENB | Active Comparator | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
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| MenACWY | Active Comparator | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal group B Vaccine, rMenB+OMV NZ | Biological | 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251. |
| Measure | Description | Time Frame |
|---|---|---|
| Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | At Day 331 (one month after the fourth vaccination) |
| hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | At Day 331 (one month after the fourth vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | At Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
History of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment.
Previous known or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
History of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine.
Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample:
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth.
History of any progressive or severe neurologic disorder, or seizure disorder or Guillan Barré syndrome (exception: one self-limited febrile seizure is acceptable).
History of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw.
Child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
Receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period.
Family members or household members of site research staff.
Any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., Down's syndrome).
History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Buenos Aires | C1425DEM | Argentina | |||
| GSK Investigational Site |
All enrolled subjects were included in the study.
750 healthy infants, aged 3 months were recruited from 3 sites in Argentina and 4 sites in Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | rMenB+ACWY Group | Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age. |
| FG001 | rMenB Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Meningococcal ACWY Conjugate Vaccine, MenACWY | Biological | 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251. |
|
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| hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | At Day 151 (one month after the third vaccination) |
| hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | At Day 301 (before the fourth vaccination) |
| hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | At Day 331 (one month after the fourth vaccination) |
| hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | At Day 1 |
| hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | At Day 151 (one month after the third vaccination) |
| hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | At Day 301 (before the fourth vaccination) |
| hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135, Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | At Day 331 (one month after the fourth vaccination) |
| Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | At Day 1 |
| Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | At Day 151 (one month after the third vaccination) |
| Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | At Day 301 (before the fourth vaccination) |
| Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | At Day 331 (One month after the fourth vaccination) |
| Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | At Day 1 |
| Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at one month after third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | At Day 151 (one month after the third vaccination) |
| Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | At Day 301 (before the fourth vaccination) |
| Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | At Day 331 (one month after the fourth vaccination) |
| Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | At Day 1 |
| Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | At Day 151 (one month after the third vaccination) |
| Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | At Day 301 (before the fourth vaccination) |
| Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | At Day 331 (one month after the fourth vaccination) |
| Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 & M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301). | At Day 331 (one month after fourth vaccination) |
| Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 & Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301). | At Day 331 (one month after the fourth vaccination) |
| Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301). This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups. For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was <2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2). | At Day 331 (one month after the fourth vaccination) |
| Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W & Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was <4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4). | At Day 331 (one month after the fourth vaccination) |
| Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | At Day 1 |
| Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | At Day 151 (one month before the third vaccination) |
| Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | At Day 301 (before the fourth vaccination) |
| Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | At Day 331 (one month after the fourth vaccination) |
| Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination | From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301) |
| Number of Subjects With Unsolicited Adverse Events | An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. | From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301) |
| Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect. | Throughout the whole study period (from Day 1 upto Day 331) |
| Buenos Aires |
| C1425EFD |
| Argentina |
| GSK Investigational Site | Córdoba | X5000JRD | Argentina |
| GSK Investigational Site | Mexico City | 04530 | Mexico |
| GSK Investigational Site | Mexico City | 06400 | Mexico |
| GSK Investigational Site | Mexico City | 06760 | Mexico |
| GSK Investigational Site | Morelia | 58070 | Mexico |
Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age.
| FG002 | MenACWY Group | Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | rMenB+ACWY Group | Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age. |
| BG001 | rMenB Group | Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age. |
| BG002 | MenACWY Group | Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age. |
| BG003 | 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against Each of the Serogroup B Indicator Strains | Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | Analysis was performed on the Per Protocol set (PPS). The PPS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination and were not excluded due to reasons defined prior to analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 331 (one month after the fourth vaccination) |
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| Primary | hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroups A, C, W-135 and Y | hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | Analysis was performed on the Per Protocol set (PPS). The PPS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination and were not excluded due to reasons defined prior to analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 331 (one month after the fourth vaccination) |
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| Secondary | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (day 1). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 |
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| Secondary | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151) | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 151 (one month after the third vaccination) |
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| Secondary | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination( Day 301). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 301 (before the fourth vaccination) |
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| Secondary | hSBA Geometric Mean Titers Against Each of the Serogroup B Indicator Strains. | hSBA GMTs against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination( Day 331). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 331 (one month after the fourth vaccination) |
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| Secondary | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1) | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 1 |
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| Secondary | hSBA Geometric Mean Titers Against Each of the Serogroups A, C, W-135 and Y | hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 151 (one month after the third vaccination) |
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| Secondary | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135, Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination(Day 301) | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 301 (before the fourth vaccination) |
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| Secondary | hSBA Geometric Mean Titers Against Each of the Serogroups A,C,W-135 & Y. | hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135, Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups A,C,W-135 & Y were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Day 331 (one month after the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline(Day 1) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151). | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 151 (one month after the third vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination(Day 301). | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 301 (before the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers ≥1:5 Against Each of the Serogroup B Strains. | Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 331 (One month after the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at baseline (day 1) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains at one month after third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 151 (one month after the third vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination(Day 301). | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 301 (before the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroup B Indicator Strains | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 331 (one month after the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the third vaccination (Day 151) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 151 (one month after the third vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample before the fourth vaccination (Day 301). | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 301 (before the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers≥1:4 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 331 (one month after the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Within-subject Geometric Mean Ratios (GMRs) Against Each of the Serogroup B Indicator Strains | Geometric Mean Ratios(GMRs) of GMTs against each of the serogroup B indicator strains- H44/76, 5/99, N98/254 & M10713 were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination(Day 301). | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination( Day 301). | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 331 (one month after fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Within-subject Geometric Mean Ratios (GMRs) Against Each of Serogroups A, C, W-135 and Y | Geometric Mean Ratios(GMRs) of GMTs against each of the serogroups A,C,W-135 & Y were calculated at one month after the fourth vaccination (Day 331) versus pre fourth vaccination (Day 301). | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination( Day 301). | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At Day 331 (one month after the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroup B Indicator Strains | Percentage of subjects with four-fold increase in hSBA titers against each of the N. meningitidis serogroup B indicator strains-H44/76,5/99,NZ98/254 & M10713 at one month after the fourth vaccination (Day 331) over pre-fourth vaccination (Day 301). This outcome measure applies to only groups rMenB+ACWY and rMenB as the serogroup B indicator strains were assessed only for these two groups. For serogroup B strains, 4-fold increase in titers was defined as post 4th vaccination titer ≥8 (if pre 4th vaccination titer was <2) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥2). | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) and before the fourth vaccination (Day 301). | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 331 (one month after the fourth vaccination) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With Four-fold Increases in hSBA Titers Against Each of the Serogroups A, C, W-135 and Y | Percentages of subjects with four-fold increases in hSBA against each of the N. meningitidis serogroups A,C,W & Y at one month after the fourth vaccination (Day 331) over pre-fourth vaccination(Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. For serogroups A, C, W and Y, 4-fold increase in titers was defined as post 4th vaccination titer ≥16 (if pre 4th vaccination titer was <4) or post 4th vaccination titer ≥ 4 x pre 4th vaccination titer (if pre 4th vaccination titer was ≥4). | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the fourth vaccination (Day 331) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 331 (one month after the fourth vaccination) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at baseline (Day 1) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the third vaccination (Day 151). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample at one month after the third vaccination (Day 151) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 151 (one month before the third vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y before the fourth vaccination (Day 301). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination and provided an evaluable serum sample before the fourth vaccination (Day 301). | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 301 (before the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects With hSBA Titers≥1:8 Against Each of the Serogroups A, C, W-135 and Y | Percentage of subjects with hSBA titers≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 & Y at one month after the fourth vaccination (Day 331). This outcome measure applies to only rMenB+ACWY and MENACWY groups as the serogroups were assessed only for these two groups. | Analysis was performed on the Full Analysis Set( FAS). The FAS included all subjects who received a study vaccination, provided an evaluable serum sample at one month after the fourth vaccination (Day 331) | Posted | Number | 95% Confidence Interval | Percentage of subjects | At Day 331 (one month after the fourth vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Solicited Local and Systemic Adverse Events (AEs) | Number of subjects with solicited local and systemic AEs during the 7 days (including the day of vaccination) after any vaccination | Analysis was performed on the Solicited Safety Set. The solicited safety set included all subjects who provide informed consent & provide demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the trial and received a subject ID and provided post vaccination solicited adverse events data | Posted | Count of Participants | Participants | From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Unsolicited Adverse Events | An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. | Analysis was performed on the Unsolicited Safety Set. The Unsolicited safety set included all subjects who provided informed consent & demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the trial and received a subject ID and provided post-vaccination unsolicited adverse event record | Posted | Count of Participants | Participants | From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With SAEs, AEs Leading to Withdrawal and Medically Attended AEs (MAEs) | A serious adverse event is any untoward medical occurrence that at any dose results in death/ is life threatening/requires prolonged hospitalization/Persistent or significant disability/incapacity/congenital anomaly/or birth defect. | Analysis was performed on the Unsolicited Safety Set. The Unsolicited safety set included all subjects who provided informed consent & demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the trial and received a subject ID and provided post-vaccination unsolicited adverse event record | Posted | Count of Participants | Participants | Throughout the whole study period (from Day 1 upto Day 331) |
|
Solicited local and systemic AEs were collected from day 1 (6 hours) upto day 7 after each vaccination. Unsolicited AEs were collected from day 1 to day 7.
Serious Adverse Events (SAEs) were collected throughout the whole study period (from day 1 to day 331).
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systematic assessment.
Out of the 750 subjects enrolled in the study, a total of 744 subjects were exposed to the study vaccine and were included in the overall safety set. Therefore, the number of subjects reporting adverse events are lesser than the number of subjects enrolled.
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 | rMenB+ACWY Group | Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age. | 0 | 249 | 6 | 249 | 240 | 249 |
| EG001 | rMenB Group | Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age | 0 | 249 | 13 | 249 | 232 | 249 |
| EG002 | MenACWY Group | Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age. | 0 | 246 | 11 | 246 | 221 | 246 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Kawasaki's disease | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Crying | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Candida nappy rash | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C570015 | 4CMenB vaccine |
| C525703 | MenACWY |
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| Other |
|
| 5/99 |
|
|
| NZ98/254 |
|
|
| M10713 |
|
|
| 5/99-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the 5/99 serogroup B indicator strain,at one month after the fourth vaccination. | ANOVA | The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group & center as factors in the model | GMT ratio | 1.03 | 2-Sided | 95 | 0.74 | 1.45 | Non-Inferiority | Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains. |
| NZ98/254-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the NZ98/254 serogroup B indicator strain,at one month after the fourth vaccination. | ANOVA | The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group & center as factors in the model | GMT ratio | 1.01 | 2-Sided | 95 | 0.82 | 1.25 | Non-Inferiority | Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains. |
| M10713-The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the M10713 serogroup B indicator strain,at one month after the fourth vaccination. | ANOVA | The 2-sided 95% CI for each between groups ratio of GMTs was constructed from an analysis of ANOVA with vaccine group & center as factors in the model | GMT ratio | 1.03 | 2-Sided | 95 | 0.77 | 1.40 | Non-Inferiority | Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains. |
| Units | Counts |
|---|
| Participants |
|
|
|
|
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| Participants |
|
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| Participants |
|
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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