| Primary | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL | Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL). | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and assay results available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Number | | Subjects | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG002 | Pentacel Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age. |
| | Units | Counts |
|---|
| Participants | - OG0001590
- OG001274
- OG002253
|
| | Title | Denominators | Categories |
|---|
| Anti-PRP ≥ 0.15 µg/mL | | | Title | Measurements |
|---|
| - OG0001536
- OG001265
- OG002234
|
| | Anti-PRP ≥ 1.0 µg/mL | |
| | 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 |
|---|
| Non-inferiority Anti-PRP concentration ≥ 1.0 μg/mL | Non-inferiority analysis | | | | difference in percentage | -8.59 | | | 2-Sided | 95 | -12.28 | -4.07 | | | | | Non-Inferiority | To demonstrate the non-inferiority of Test Hib to Control Hib, each co-administered with DTPa-HBV-IPV, 13Pn and HRV vaccines, following 3 primary vaccine doses in terms of anti-PRP antibody concentration ≥ 1.0 μg/mL. | | |
|
| Primary | Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) | Non-inferiority of Pediarix co-administered with Hiberix, Prevnar13 and Rotarix compared to Pediarix co-administered with ActHIB, Prevnar13 and Rotarix following 3 primary vaccine doses in terms of immune response to Diphtheria, Tetanus. | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Number | | Subjects | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Primary | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL). | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Primary | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL. | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Primary | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Primary | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group. | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Number | | Subjects | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Primary | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity). The polio testing which started at the Biomnis laboratory was stopped because the polio virus micro-neutralization assays were found to be not in line with the quality standards defined in GSK Biologicals' SOPs. As a result, polio testing was restarted at the GSK laboratory and the results were uploaded into the clinical database. | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Number | | Subjects | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 |
|
| Primary | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL | Non-inferiority of a booster dose of Hiberix co-administered with Infanrix in subjects 15-18 months of age who received 3 primary vaccine doses of Hiberix to a booster dose of ActHIB co-administered with Infanrix in subjects of 15-18 months of age who received 3 primary vaccine doses of ActHIB in terms of immune response to PRP | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose | Posted | | Number | | Subjects | | At 1 month after booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | |
|
| Secondary | Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations | Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | IU/mL | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. |
|
| Secondary | Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade. | The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and with symptom sheets completed. | Posted | | Number | | Subjects | | During a 4-day follow-up period (Days 0-3) following any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Secondary | Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C). | The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and symptom sheets completed. | Posted | | Number | | Subjects | | During a 4-day follow-up period (Days 0-3) following any vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| 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 based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented. | Posted | | Number | | Subjects | | During the 31-day (Day 0-Day 30) follow-up period after primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | |
|
| 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 based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented. | Posted | | Number | | Subjects | | From Day 0 until 6 months following the last primary dose | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Secondary | Number of Subjects With AEs of Specific Interest (AESIs) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented. | Posted | | Number | | Subjects | | From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Secondary | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group. | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Number | | Subjects | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Secondary | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Seroresponse was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group. | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Number | | Subjects | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
|
| Secondary | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Evaluation of persistence of anti-PRP antibodies induced by three primary vaccine doses of Hiberix, and ActHIB, each co-administered with Pediarix, Prevnar 13 and Rotarix, or Pentacel co-administered with Engerix-B, Rotarix and Prevnar 13 prior to the booster dose of Hiberix, ActHIB or Pentacel at 15-18 months of age and evaluation of immunogenicity of a booster dose of Hiberix co-administered with Infanrix, ActHIB co-administered with Infanrix and Pentacel in terms of the percentage of subjects with anti-PRP concentrations ≥0.15 µg/mL, ≥1.0 µg/mL and GMCs one month after the booster dose. | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose | Posted | | Number | | Subjects | | Prior to the booster vaccination and 1 month after the booster vaccination | | | | ID | Title | Description |
|---|
| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations | Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL). | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | Evaluation of immunogenicity of a 3-dose primary vaccination course of Prevnar 13 co-administered with Hiberix, Rotarix and Pediarix, of Prevnar 13 co-administered with ActHIB, Rotarix and Pediarix and of Prevnar 13 co-administered with Pentacel, Rotarix and Engerix-B in terms of S.pneumoniae GMCs and antibody concentrations ≥ 0.05µg/mL, ≥ 0.2 µg/mL, ≥ 1.0 µg/mL at one month after the last dose of primary vaccination. | The analysis was based on the Primary According-to-Protocol (ATP)cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Number | | Subjects | | At 1 month after the last dose of primary vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 |
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| Secondary | Antibody Titers for Poliovirus Types 1, 2 and 3 | Antibody titers were given as geometric mean titers(GMTs). | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values | The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection). | The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose. | Posted | | Number | | Subjects | | At 1 month after last dose of primary vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations | Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL). | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | Prior to the booster vaccination and 1 month after the booster vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL | Antibody concentrations were expressed as geometric mean concentrations (GMCs) and expressed as milli-international units per milliliter (mIU/mL). | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | mIU/mL | | Prior to the booster vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL | The cut-off values were defined as a concentration≥ 6.2 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection). | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose | Posted | | Number | | Subjects | | Prior to booster vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Evaluation of persistence of anti-PT, anti-FHA and anti-PRN antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-PT, anti-FHA and anti- PRN antibodies. | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose. | Posted | | Number | | Subjects | | Prior to the booster vaccination and 1 month after the booster vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 |
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| Secondary | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Antibody concentrations were tabulated as geometric mean titers (GMTs) and expressed as titers. | The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | Prior to the booster vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 1,2,3 antibody titers greater or equal to the cut off value were calculated. | The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose. | Posted | | Number | | Subjects | | Prior to booster vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally |
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| Secondary | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Evaluation of persistence of anti-D, anti-T antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-D and anti-T antibodies. | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose. | Posted | | Number | | Subjects | | Prior to the booster vaccination and 1 month after the booster vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 |
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| Secondary | Number of Subjects With Any Solicited Local Symptoms | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade. | Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed. | Posted | | Number | | Subjects | | Within 4 days (Days 0-3) following the booster dose | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Number of Subjects With Any Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Axillary temperature equal to or above (≥) 38 degrees Celsius (°C). | Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed. | Posted | | Number | | Subjects | | Within 4 days (Days 0-3) following the booster dose | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Number of Subjects With AEs of Specific Interest (AESIs) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. | Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose. | Posted | | Number | | Subjects | | From booster dose until 6 months following receipt of the booster dose | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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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. | Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose. | Posted | | Number | | Subjects | | Within 31 days (Day 0 to Day 30) following the booster dose | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose. | Posted | | Number | | Subjects | | From the booster dose until 6 months following receipt of the booster dose | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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| Secondary | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL. | The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | pre-booster and one month after booster vaccination | | | | ID | Title | Description |
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| OG000 | Hiberix Group | Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | | OG001 | ActHIB Group | Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. |
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