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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000254-64 | EudraCT Number |
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The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.
This protocol posting has been updated according to Protocol Amendment 2, September 2010. The impacted sections are arms and inclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tritanrix-HepB/Hib+Polio Sabin <6S Group | Experimental | Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
|
| Tritanrix-HepB/Hib+Polio Sabin <6NS Group | Active Comparator | Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
|
| Synflorix 7-11S Group | Experimental | Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
|
| Synflorix 7-11NS Group | Active Comparator | Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1024850A (Synflorix) | Biological | 2, 3 or 4 intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | One month after primary vaccination (Month 3) |
| Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | One month after the primary vaccination (Month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. |
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Inclusion Criteria:
Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
A male or female between, and including:
Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
Additional inclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
Additional inclusion criteria for healthy children (<6NS, 7-11NS and 12-23NS groups):
Exclusion Criteria:
Child in care
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Previous vaccination or planned vaccination during the study with any pneumococcal vacccine.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
Major congenital malformations.
History of any neurological disorders or seizures.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Birth weight below 1500g.
Serious chronic illness other than SCD.
Acute disease and/or fever at the time of enrolment.
Additional exclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
• Any confirmed or suspected immunosuppressive or immunodeficient condition, (including human immunodeficiency virus (HIV) infection) other than SCD related conditions, based on medical history and physical examination (no laboratory testing required).
Additional exclusion criteria for healthy children (<6 NS, 7-11NS and 12-23NS groups):
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Ouagadougou | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28403055 | Background | Sirima SB, Tiono A, Gansane Z, Siribie M, Zongo A, Ouedraogo A, Francois N, Strezova A, Dobbelaere K, Borys D. Immunogenicity and Safety of 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Administered to Children With Sickle Cell Disease Between 8 Weeks and 2 Years of Age: A Phase III, Open, Controlled Study. Pediatr Infect Dis J. 2017 May;36(5):e136-e150. doi: 10.1097/INF.0000000000001518. |
| 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 |
|---|---|---|---|
| 114056 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tritanrix-HepB/Hib+Polio Sabin <6S Group | Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| FG001 | Tritanrix-HepB/Hib+Polio Sabin <6NS Group | Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| FG002 | Synflorix 7-11S Group | Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| FG003 | Synflorix 7-11NS Group | Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| FG004 | Synflorix 12-23S Group | Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
| FG005 | Synflorix 12-23NS Group | Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Epoch |
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| Booster Epoch |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tritanrix-HepB/Hib+Polio Sabin <6S Group | Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| 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 |
| 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 | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the According To Protocol (ATP) immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at Month 3. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One month after primary vaccination (Month 3) |
Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tritanrix-HepB/Hib+Polio Sabin <6S Group | Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enteritis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D011008 | Pneumococcal Infections |
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C547294 | PHiD-CV vaccine |
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|
| Synflorix 12-23S Group | Experimental | Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
|
| Synflorix 12-23NS Group | Active Comparator | Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
|
| Tritanrix-HepB/Hib | Biological | Intramuscular injection, 4 doses |
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| Polio Sabin | Biological | 4 oral doses |
|
|
| Prior to the primary vaccination (Month 0), prior to (Month 8) and one month after (Month 9) booster vaccination |
| Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
| Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
| Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
| Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | Prior to (Month 0) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
| Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
| Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
| Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
| Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
| Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
| Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
| Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
| Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
| Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine | Anti-DT and anti-TT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). Seroprotection status was defined as anti-DT or anti-TT antibody concentration ≥ than 0.1 IU/mL. | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
| Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine | Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 15 EL.U/mL. | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | During the 4-day (Days 0-3) post-booster vaccination period |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal 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. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal 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. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 4-day (Days 0-3) post-booster vaccination period |
| 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. | Within the 31-day (Days 0-30) post-primary and post-booster vaccination period |
| 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. | During the entire study period from Month 0 to Month 9 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114056 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114056 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114056 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114056 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114056 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114056 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Lost to Follow-up |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| Tritanrix-HepB/Hib+Polio Sabin <6NS Group |
Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| BG002 | Synflorix 7-11S Group | Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| BG003 | Synflorix 7-11NS Group | Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| BG004 | Synflorix 12-23S Group | Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
| BG005 | Synflorix 12-23NS Group | Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
| BG006 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Tritanrix-HepB/Hib+Polio Sabin <6S Group | Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| OG001 | Tritanrix-HepB/Hib+Polio Sabin <6NS Group | Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
|
|
| Primary | Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at Month 3. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month after the primary vaccination (Month 3) |
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| Secondary | Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Prior to the primary vaccination (Month 0), prior to (Month 8) and one month after (Month 9) booster vaccination |
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|
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| Secondary | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
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| Secondary | Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Antibodies have been assessed against the following vaccine pneumococcal serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
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| Secondary | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
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| Secondary | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
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| Secondary | Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
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| Secondary | Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior to (Month 0) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
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| Secondary | Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
|
|
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| Secondary | Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
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| Secondary | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
|
|
|
| Secondary | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
|
|
|
| Secondary | Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
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|
|
| Secondary | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines | Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
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|
|
| Secondary | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose | Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination |
|
|
|
| Secondary | Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose | Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose |
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| Secondary | Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine | Anti-DT and anti-TT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). Seroprotection status was defined as anti-DT or anti-TT antibody concentration ≥ than 0.1 IU/mL. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Tritanrix-HepB/Hib vaccine, for whom data concerning immunogenicity outcomes and assay results for antibodies against diphtheria and tetanus toxoids were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
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| Secondary | Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine | Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 15 EL.U/mL. | The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Tritanrix-HepB/Hib vaccine, for whom data concerning immunogenicity outcomes and assay results for antibodies against Bordetella pertussis were available at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort for the primary epoch, which included all vaccinated subjects who completed their symptoms sheet for the respective dose. Note that dose 3 rows are not applicable for subjects from the 7-11 and 12-23 months of age groups as they only received a 2-dose primary vaccination. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. | The analysis was performed on the Total Vaccinated cohort for the booster epoch, which included all booster vaccinated subjects who completed their symptoms sheet. Note that no data are reported for the 12-23 months of age groups as they were not administered any vaccine during the booster phase. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-booster vaccination period |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal 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. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort for the primary epoch, which included all vaccinated subjects who completed their symptoms sheet for the respective dose. Note that dose 3 rows are not applicable for subjects from the 7-11 and 12-23 months of age groups as they only received a 2-dose primary vaccination. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses |
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| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal 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. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort for the booster epoch, which included all booster vaccinated subjects who completed their symptoms sheet. Note that no data are reported for the 12-23 months of age groups as they were not administered any vaccine during the booster phase. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-booster vaccination period |
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| 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. | The analysis was performed on the Total Vaccinated cohort for the primary and booster epochs, which included all vaccinated subjects who received at least one dose of primary vaccination and the booster dose of study vaccine, respectively. Note that subjects from the 12-23 months of age groups did not participate in the Booster Epoch. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) post-primary and post-booster vaccination period |
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| 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. | The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccination. | Posted | Count of Participants | Participants | During the entire study period from Month 0 to Month 9 |
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|
|
| 1 |
| 50 |
| 3 |
| 50 |
| 50 |
| 50 |
| EG001 | Tritanrix-HepB/Hib+Polio Sabin <6NS Group | Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. | 1 | 50 | 9 | 50 | 49 | 50 |
| EG002 | Synflorix 7-11S Group | Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. | 1 | 50 | 3 | 50 | 47 | 50 |
| EG003 | Synflorix 7-11NS Group | Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. | 0 | 50 | 4 | 50 | 47 | 50 |
| EG004 | Synflorix 12-23S Group | Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. | 0 | 50 | 2 | 50 | 41 | 50 |
| EG005 | Synflorix 12-23NS Group | Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. | 0 | 50 | 2 | 50 | 31 | 50 |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Gastroenteritis rotavirus | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Meningitis salmonella | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Osteomyelitis acute | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 18.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Gastrointestinal fungal infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA 18.0 | 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.
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Anti-1, Month 8 |
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| Anti-1, Month 9 |
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| Anti-4, Month 0 |
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| Anti-4, Month 8 |
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| Anti-4, Month 9 |
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| Anti-5, Month 0 |
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| Anti-5, Month 8 |
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| Anti-5, Month 9 |
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| Anti-6B, Month 0 |
|
|
| Anti-6B, Month 8 |
|
|
| Anti-6B, Month 9 |
|
|
| Anti-7F, Month 0 |
|
|
| Anti-7F, Month 8 |
|
|
| Anti-7F, Month 9 |
|
|
| Anti-9V, Month 0 |
|
|
| Anti-9V, Month 8 |
|
|
| Anti-9V, Month 9 |
|
|
| Anti-14, Month 0 |
|
|
| Anti-14, Month 8 |
|
|
| Anti-14, Month 9 |
|
|
| Anti-18C, Month 0 |
|
|
| Anti-18C, Month 8 |
|
|
| Anti-18C, Month 9 |
|
|
| Anti-19F, Month 0 |
|
|
| Anti-19F, Month 8 |
|
|
| Anti-19F, Month 9 |
|
|
| Anti-23F, Month 0 |
|
|
| Anti-23F, Month 8 |
|
|
| Anti-23F, Month 9 |
|
|
| Anti-1, Month 2 |
|
|
| Anti-1, Month 3 |
|
|
| Anti-1, Month 4 |
|
|
| Anti-4, Month 0 |
|
|
| Anti-4, Month 2 |
|
|
| Anti-4, Month 3 |
|
|
| Anti-4, Month 4 |
|
|
| Anti-5, Month 0 |
|
|
| Anti-5, Month 2 |
|
|
| Anti-5, Month 3 |
|
|
| Anti-5, Month 4 |
|
|
| Anti-6B, Month 0 |
|
|
| Anti-6B, Month 2 |
|
|
| Anti-6B, Month 3 |
|
|
| Anti-6B, Month 4 |
|
|
| Anti-7F, Month 0 |
|
|
| Anti-7F, Month 2 |
|
|
| Anti-7F, Month 3 |
|
|
| Anti-7F, Month 4 |
|
|
| Anti-9V, Month 0 |
|
|
| Anti-9V, Month 2 |
|
|
| Anti-9V, Month 3 |
|
|
| Anti-9V, Month 4 |
|
|
| Anti-14, Month 0 |
|
|
| Anti-14, Month 2 |
|
|
| Anti-14, Month 3 |
|
|
| Anti-14, Month 4 |
|
|
| Anti-18C, Month 0 |
|
|
| Anti-18C, Month 2 |
|
|
| Anti-18C, Month 3 |
|
|
| Anti-18C, Month 4 |
|
|
| Anti-19F, Month 0 |
|
|
| Anti-19F, Month 2 |
|
|
| Anti-19F, Month 3 |
|
|
| Anti-19F, Month 4 |
|
|
| Anti-23F, Month 0 |
|
|
| Anti-23F, Month 2 |
|
|
| Anti-23F, Month 3 |
|
|
| Anti-23F, Month 4 |
|
|
| Anti-1, Month 2 |
|
|
| Anti-1, Month 3 |
|
|
| Anti-4, Month 0 |
|
|
| Anti-4, Month 2 |
|
|
| Anti-4, Month 3 |
|
|
| Anti-5, Month 0 |
|
|
| Anti-5, Month 2 |
|
|
| Anti-5, Month 3 |
|
|
| Anti-6B, Month 0 |
|
|
| Anti-6B, Month 2 |
|
|
| Anti-6B, Month 3 |
|
|
| Anti-7F, Month 0 |
|
|
| Anti-7F, Month 2 |
|
|
| Anti-7F, Month 3 |
|
|
| Anti-9V, Month 0 |
|
|
| Anti-9V, Month 2 |
|
|
| Anti-9V, Month 3 |
|
|
| Anti-14, Month 0 |
|
|
| Anti-14, Month 2 |
|
|
| Anti-14, Month 3 |
|
|
| Anti-18C, Month 0 |
|
|
| Anti-18C, Month 2 |
|
|
| Anti-18C, Month 3 |
|
|
| Anti-19F, Month 0 |
|
|
| Anti-19F, Month 2 |
|
|
| Anti-19F, Month 3 |
|
|
| Anti-23F, Month 0 |
|
|
| Anti-23F, Month 2 |
|
|
| Anti-23F, Month 3 |
|
|
| Anti-6A, Month 3 |
|
|
| Anti-6A, Month 8 |
|
|
| Anti-6A, Month 9 |
|
|
| Anti-19A, Month 0 |
|
|
| Anti-19A, Month 3 |
|
|
| Anti-19A, Month 8 |
|
|
| Anti-19A, Month 9 |
|
|
| Anti-6A, Month 2 |
|
|
| Anti-6A, Month 3 |
|
|
| Anti-6A, Month 4 |
|
|
| Anti-19A, Month 0 |
|
|
| Anti-19A, Month 2 |
|
|
| Anti-19A, Month 3 |
|
|
| Anti-19A, Month 4 |
|
|
| Anti-6A, Month 2 |
|
|
| Anti-6A, Month 3 |
|
|
| Anti-19A, Month 0 |
|
|
| Anti-19A, Month 2 |
|
|
| Anti-19A, Month 3 |
|
|
| Anti-PD, Month 8 |
|
|
| Anti-PD, Month 9 |
|
|
| Anti-PD, Month 2 |
|
|
| Anti-PD, Month 3 |
|
|
| Anti-PD, Month 4 |
|
|
| Anti-PD, Month 2 |
|
|
| Anti-PD, Month 3 |
|
|
| OPA-1, Month 8 |
|
|
| OPA-1, Month 9 |
|
|
| OPA-4, Month 3 |
|
|
| OPA-4, Month 8 |
|
|
| OPA-4, Month 9 |
|
|
| OPA-5, Month 3 |
|
|
| OPA-5, Month 8 |
|
|
| OPA-5, Month 9 |
|
|
| OPA-6B, Month 3 |
|
|
| OPA-6B, Month 8 |
|
|
| OPA-6B, Month 9 |
|
|
| OPA-7F, Month 3 |
|
|
| OPA-7F, Month 8 |
|
|
| OPA-7F, Month 9 |
|
|
| OPA-9V, Month 3 |
|
|
| OPA-9V, Month 8 |
|
|
| OPA-9V, Month 9 |
|
|
| OPA-14, Month 3 |
|
|
| OPA-14, Month 8 |
|
|
| OPA-14, Month 9 |
|
|
| OPA-18C, Month 3 |
|
|
| OPA-18C, Month 8 |
|
|
| OPA-18C, Month 9 |
|
|
| OPA-19F, Month 3 |
|
|
| OPA-19F, Month 8 |
|
|
| OPA-19F, Month 9 |
|
|
| OPA-23F, Month 3 |
|
|
| OPA-23F, Month 8 |
|
|
| OPA-23F, Month 9 |
|
|
| OPA-1, Month 2 |
|
|
| OPA-1, Month 3 |
|
|
| OPA-1, Month 4 |
|
|
| OPA-4, Month 0 |
|
|
| OPA-4, Month 2 |
|
|
| OPA-4, Month 3 |
|
|
| OPA-4, Month 4 |
|
|
| OPA-5, Month 0 |
|
|
| OPA-5, Month 2 |
|
|
| OPA-5, Month 3 |
|
|
| OPA-5, Month 4 |
|
|
| OPA-6B, Month 0 |
|
|
| OPA-6B, Month 2 |
|
|
| OPA-6B, Month 3 |
|
|
| OPA-6B, Month 4 |
|
|
| OPA-7F, Month 0 |
|
|
| OPA-7F, Month 2 |
|
|
| OPA-7F, Month 3 |
|
|
| OPA-7F, Month 4 |
|
|
| OPA-9V, Month 0 |
|
|
| OPA-9V, Month 2 |
|
|
| OPA-9V, Month 3 |
|
|
| OPA-9V, Month 4 |
|
|
| OPA-14, Month 0 |
|
|
| OPA-14, Month 2 |
|
|
| OPA-14, Month 3 |
|
|
| OPA-14, Month 4 |
|
|
| OPA-18C, Month 0 |
|
|
| OPA-18C, Month 2 |
|
|
| OPA-18C, Month 3 |
|
|
| OPA-18C, Month 4 |
|
|
| OPA-19F, Month 0 |
|
|
| OPA-19F, Month 2 |
|
|
| OPA-19F, Month 3 |
|
|
| OPA-19F, Month 4 |
|
|
| OPA-23F, Month 0 |
|
|
| OPA-23F, Month 2 |
|
|
| OPA-23F, Month 3 |
|
|
| OPA-23F, Month 4 |
|
|
| OPA-1, Month 2 |
|
|
| OPA-1, Month 3 |
|
|
| OPA-4, Month 0 |
|
|
| OPA-4, Month 2 |
|
|
| OPA-4, Month 3 |
|
|
| OPA-5, Month 0 |
|
|
| OPA-5, Month 2 |
|
|
| OPA-5, Month 3 |
|
|
| OPA-6B, Month 0 |
|
|
| OPA-6B, Month 2 |
|
|
| OPA-6B, Month 3 |
|
|
| OPA-7F, Month 0 |
|
|
| OPA-7F, Month 2 |
|
|
| OPA-7F, Month 3 |
|
|
| OPA-9V, Month 0 |
|
|
| OPA-9V, Month 2 |
|
|
| OPA-9V, Month 3 |
|
|
| OPA-14, Month 0 |
|
|
| OPA-14, Month 2 |
|
|
| OPA-14, Month 3 |
|
|
| OPA-18C, Month 0 |
|
|
| OPA-18C, Month 2 |
|
|
| OPA-18C, Month 3 |
|
|
| OPA-19F, Month 0 |
|
|
| OPA-19F, Month 2 |
|
|
| OPA-19F, Month 3 |
|
|
| OPA-23F, Month 0 |
|
|
| OPA-23F, Month 2 |
|
|
| OPA-23F, Month 3 |
|
|
| OPA-6A, Month 8 |
|
|
| OPA-6A, Month 9 |
|
|
| OPA-19A, Month 3 |
|
|
| OPA-19A, Month 8 |
|
|
| OPA-19A, Month 9 |
|
|
| OPA-6A, Month 2 |
|
|
| OPA-6A, Month 3 |
|
|
| OPA-6A, Month 4 |
|
|
| OPA-19A, Month 0 |
|
|
| OPA-19A, Month 2 |
|
|
| OPA-19A, Month 3 |
|
|
| OPA-19A, Month 4 |
|
|
| OPA-6A, Month 2 |
|
|
| OPA-6A, Month 3 |
|
|
| OPA-19A, Month 0 |
|
|
| OPA-19A, Month 2 |
|
|
| OPA-19A, Month 3 |
|
|
| Anti-DT, Month 3 |
|
|
| Anti-DT, Month 8 |
|
|
| Anti-DT, Month 9 |
|
|
| Anti-TT, Month 0 |
|
|
| Anti-TT, Month 3 |
|
|
| Anti-TT, Month 8 |
|
|
| Anti-TT, Month 9 |
|
|
| Anti-BPT, Month 3 |
|
|
| Anti-BPT, Month 8 |
|
|
| Anti-BPT, Month 9 |
|
|
|
| Grade 3 Pain, Dose 1 |
|
|
| Any Redness, Dose 1 |
|
|
| Grade 3 Redness, Dose 1 |
|
|
| Any Swelling, Dose 1 |
|
|
| Grade 3 Swelling, Dose 1 |
|
|
| Any Pain, Dose 2 |
|
|
| Grade 3 Pain, Dose 2 |
|
|
| Any Redness, Dose 2 |
|
|
| Grade 3 Redness, Dose 2 |
|
|
| Any Swelling, Dose 2 |
|
|
| Grade 3 Swelling, Dose 2 |
|
|
| Any Pain, Dose 3 |
|
|
| Grade 3 Pain, Dose 3 |
|
|
| Any Redness, Dose 3 |
|
|
| Grade 3 Redness, Dose 3 |
|
|
| Any Swelling, Dose 3 |
|
|
| Grade 3 Swelling, Dose 3 |
|
|
| Any Pain, Across doses |
|
|
| Grade 3 Pain, Across doses |
|
|
| Any Redness, Across doses |
|
|
| Grade 3 Redness, Across doses |
|
|
| Any Swelling, Across doses |
|
|
| Grade 3 Swelling, Across doses |
|
|
| Grade 3 Pain |
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
|
| Grade 3 Drowsiness, Dose 1 |
|
|
| Related Drowsiness, Dose 1 |
|
|
| Any Irritability, Dose 1 |
|
|
| Grade 3 Irritability, Dose 1 |
|
|
| Related Irritability, Dose 1 |
|
|
| Any Loss of appetite, Dose 1 |
|
|
| Grade 3 Loss of appetite, Dose 1 |
|
|
| Related Loss of appetite, Dose 1 |
|
|
| Any Fever, Dose 1 |
|
|
| Grade 3 Fever, Dose 1 |
|
|
| Related Fever, Dose 1 |
|
|
| Any Drowsiness, Dose 2 |
|
|
| Grade 3 Drowsiness, Dose 2 |
|
|
| Related Drowsiness, Dose 2 |
|
|
| Any Irritability, Dose 2 |
|
|
| Grade 3 Irritability, Dose 2 |
|
|
| Related Irritability, Dose 2 |
|
|
| Any Loss of appetite, Dose 2 |
|
|
| Grade 3 Loss of appetite, Dose 2 |
|
|
| Related Loss of appetite, Dose 2 |
|
|
| Any Fever, Dose 2 |
|
|
| Grade 3 Fever, Dose 2 |
|
|
| Related Fever, Dose 2 |
|
|
| Any Drowsiness, Dose 3 |
|
|
| Grade 3 Drowsiness, Dose 3 |
|
|
| Related Drowsiness, Dose 3 |
|
|
| Any Irritability, Dose 3 |
|
|
| Grade 3 Irritability, Dose 3 |
|
|
| Related Irritability, Dose 3 |
|
|
| Any Loss of appetite, Dose 3 |
|
|
| Grade 3 Loss of appetite, Dose 3 |
|
|
| Related Loss of appetite, Dose 3 |
|
|
| Any Fever, Dose 3 |
|
|
| Grade 3 Fever, Dose 3 |
|
|
| Related Fever, Dose 3 |
|
|
| Any Drowsiness, Across doses |
|
|
| Grade 3 Drowsiness, Across doses |
|
|
| Related Drowsiness, Across doses |
|
|
| Any Irritability, Across doses |
|
|
| Grade 3 Irritability, Across doses |
|
|
| Related Irritability, Across doses |
|
|
| Any Loss of appetite, Across doses |
|
|
| Grade 3 Loss of appetite, Across doses |
|
|
| Related Loss of appetite, Across doses |
|
|
| Any Fever, Across doses |
|
|
| Grade 3 Fever, Across doses |
|
|
| Related Fever, Across doses |
|
|
| Grade 3 Drowsiness |
|
| Related Drowsiness |
|
| Any Irritability |
|
| Grade 3 Irritability |
|
| Related Irritability |
|
| Any Loss of appetite |
|
| Grade 3 Loss of appetite |
|
| Related Loss of appetite |
|
| Any Fever |
|
| Grade 3 Fever |
|
| Related Fever |
|
|
| Any AE(s), post-booster vaccination |
|
|