| Primary | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 001) | Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for the 10 vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. | The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine | | | | ID | Title | Description |
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| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). | | OG001 | Synflorix Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). |
| | | Title | Denominators | Categories |
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| ANTI-1 | | | Title | Measurements |
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| - OG0002.78(2.43 to 3.18)
- OG0013.03(2.60 to 3.54)
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| | ANTI-4 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| (Synflorix/10Pn_4d) antibody GMCs ratio for ANTI-1 serotype: to demonstrate non-inferiority of 10Pn-PD-DiT vaccine (4-dose presentation) as compared to 10Pn-PD-DiT vaccine (1-dose presentation) in terms of immune response, 1 month after dose 3. Criterion: the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the geometric mean antibody concentration (GMC) ratios (Synflorix/10Pn_4d) should be below a limit of 2-fold for each of the 10 serotypes. | | | | | GMCs ratio | 1.09 | | | 2-Sided | 95 | 0.89 | 1.33 | | | | | Non-Inferiority | GMCs ratio and its 95 % CI were obtained using an ANOVA model on the logarithm-10 transformed concentrations-pooled variance. |
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| Secondary | Antibody Concentrations Against Pneumococcal Serotypes (Epoch 002) | Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. | The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine | | | | ID | Title | Description |
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| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). |
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| Secondary | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 001) | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, 19 A ,-19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. | The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). |
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| Secondary | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes (Epoch 002) | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. | The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At study Month 8 and Month 9, e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). |
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| Secondary | Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 001) | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL. | The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 001 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning primary immunogenicity outcomes measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At study Month 4, e. g. at one month post-Dose 3 of pneumococcal vaccine | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). | | OG001 |
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| Secondary | Concentrations of Antibodies Against Protein D (Anti-PD) (Epoch 002) | Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL. | The analysis was performed on the According To Protocol cohort for immunogenicity of Epoch 002 which included all evaluable subjects (i.e., those meeting eligibility criteria, complied with procedures and intervals defined in protocol, with no elimination criteria) for whom data concerning booster immunogenicity outcomes measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At study Month 9, e.g.: at one month post booster vaccination with pneumococcal vaccine | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). | | OG001 |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 001) | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age. Dose 4 = 10Pn-PD-DIT at 18 weeks of age. | The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms (Epoch 002) | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). | The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). | | OG001 | Synflorix Group |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination(Epoch 001) | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 39.5°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Dose 1 = 10Pn-PD-DIT+DTPw-HBV/Hib at 6 weeks of age. Dose 2 = 10Pn-PD-DIT+DTPw-HBV/Hib at 10 weeks of age. Dose 4 = 10Pn-PD-DIT at 18 weeks of age. | The analysis was performed on the Total vaccinated cohort of Epoch 001 included all subjects who had received at least one dose of primary vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) post-vaccination period following each primary dose of 10Pn-PD-DiTvaccine | | | | ID | Title | Description |
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| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination (Epoch 002) | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever (axillary route - temperature equal or higher than [≥] 37.5 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (Axillary) temperature higher than (>) 39.5°C. | The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available. | Posted | | Count of Participants | | Participants | | Within the 4-day (Days 0-3) period after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 001) | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. | The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination. | Posted | | Count of Participants | | Participants | | Within the 31-day (Days 0-30) period post primary vaccination, across doses | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). |
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| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) (Epoch 002) | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. | The analysis was performed on the Total vaccinated cohort of Epoch 002 included all subjects who had received the booster vaccination, with analysis done solely on subjects for whom post-vaccination results about solicited or unsolicited symptoms were available. | Posted | | Count of Participants | | Participants | | Within the 31-day (Days 0-30) period post booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). |
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| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) (Epoch 001) | An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination. | The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination. | Posted | | Count of Participants | | Participants | | From Month 0 to Month 4 | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). | | OG001 |
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| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study | An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination. | The analysis was performed on the Total vaccinated cohort of Epoch 001 which included all subjects who had received at least one dose of primary vaccination. | Posted | | Count of Participants | | Participants | | From Day 0 to Month 9 | | | | ID | Title | Description |
|---|
| OG000 | 10Pn_4d Group | Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination - Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh). | |
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