Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pneumococcal conjugate vaccine GSK 1024850A · 8 trials · 2 indications
The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.
Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.
Antibodies assessed were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C,19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
The cut-off for core fever was 38.0 degrees Celsius (ºC).
A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (\>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome.
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 of Synflorix or Infanrix hexa vaccine.
Fever was measured as rectal temperature. Assessment of occurrences of fever \> 39.0 °C was performed post doses 1, 2 and 3 and across doses of Synflorix™ or Prevenar™ vaccine.
| Arm | Type | Description |
|---|---|---|
| Pn Group | EXPERIMENTAL | Subjects receiving GSK 1024850A vaccine. |
| Prev Group | ACTIVE_COMPARATOR | Subjects receiving Prevenar™ vaccine. |
| 10Pn3+1-6W- 6M/043 Group | EXPERIMENTAL | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. |
| 10Pn2+1-6W-6M/043 Group | EXPERIMENTAL | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. |
| Ctrl-6W-6M/043 Group | ACTIVE_COMPARATOR | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to either a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule), or according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. |
| 10Pn7-11M/043 Group | EXPERIMENTAL | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. |
| Ctrl7-11M/043 Group | ACTIVE_COMPARATOR | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (11-17M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. |
| 10Pn12-18M/043 Group | EXPERIMENTAL | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. |
| Ctrl12-18M/043 Group | ACTIVE_COMPARATOR | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-043 (NCT00861380 - EUDRACT 2008-005149-48) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate. |
| Synflorix & Tritanrix-HebB/Hib Group | EXPERIMENTAL | Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) |
| Hiberix group & Tritanrix-HebB Group | ACTIVE_COMPARATOR | Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) |
| Synflorix™ Group 1 | EXPERIMENTAL | Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age. |
| Synflorix™ Group 2 | EXPERIMENTAL | Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age. |
| Unprimed Group | ACTIVE_COMPARATOR | Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age. |
| Synflorix I Group | EXPERIMENTAL | Subjects were vaccinated with 3 primary vaccination doses of Synflorix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment. |
| Synflorix II Group | EXPERIMENTAL | Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment |
| Synflorix PRE Group | EXPERIMENTAL | Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment. |
| Synflorix POST Group | EXPERIMENTAL | Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment. |
| Mencevax + Infanrix Hexa Group | ACTIVE_COMPARATOR | Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine. |
| Synflorix Group | EXPERIMENTAL | Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose). |
| Control Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh. |
| Synflorix™ + Infanrix™ hexa Group I | EXPERIMENTAL | Very preterm infants born after a gestation period of 27-30 weeks (189-216 days) |
| Synflorix™ + Infanrix™ hexa Group II | EXPERIMENTAL | Mild pretem infants born after a gestation period of 31-36 weeks (217-258 days) |
| Synflorix™ + Infanrix™ hexa Group III | EXPERIMENTAL | Infants born after a gestation period of more than 36 weeks (more than 258 days) |
| Synflorix 1 Group | EXPERIMENTAL | Subjects aged 6-12 weeks from the Philippines receiving Synflorix™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ vaccines at 6, 10, 14 weeks of age. |
| Synflorix 2 Group | EXPERIMENTAL | Subjects aged 6-12 weeks from Poland receiving Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 2, 4, 6 months of age. |
| Prevenar 1 Group | ACTIVE_COMPARATOR | Subjects aged 6-12 weeks from the Philippines receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Polio Sabin™ at 6, 10, 14 weeks of age. |
| Prevenar 2 Group | ACTIVE_COMPARATOR | Subjects aged 6-12 weeks from Poland receiving the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ at 2, 4, 6 months of age. |
| Name | Type | Description |
|---|---|---|
| Pneumococcal conjugate vaccine GSK 1024850A | BIOLOGICAL | One dose of vaccine will be injected intramuscularly into the deltoid. |
| Pneumococcal conjugate vaccine Prevenar™ (Wyeth Lederle's) | BIOLOGICAL | One dose of vaccine will be injected intramuscularly into the deltoid. |
| Pneumococcal conjugate vaccine GSK1024850A | BIOLOGICAL | 2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination |
| GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine) | BIOLOGICAL | 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination. Control 3+1 and Control 2+1 groups, only for children \< 12 months of age at the time of first study vaccination. |
| GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine) | BIOLOGICAL | 2 Intramuscular injections. Control 3+1 and Control 2+1 groups, only for children \>= 12 months of age at the time of first study vaccination. |
| Tritanrix-HepB/Hib | BIOLOGICAL | Intramuscular injection, 3 doses |
| Hiberix | BIOLOGICAL | Intramuscular injection, 3 doses |
| Tritanrix-HepB | BIOLOGICAL | Intramuscular injection, 3 doses |
| Pneumococcal conjugate vaccine GSK1024850A. | BIOLOGICAL | 1 intramuscular injection. |
| Infanrix hexa. | BIOLOGICAL | 1 intramuscular injection. |
| Meningococcal vaccine GSK134612. | BIOLOGICAL | 1 intramuscular injection. |
| Paracetamol. | DRUG | Body weight of \< 7 kg: none; Body weight of ≥ 7 kg to \< 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination. |
| Havrix | BIOLOGICAL | Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group |
| Engerix-B | BIOLOGICAL | Intramuscular injection, 3 doses |
| Infanrix hexa | BIOLOGICAL | Intramuscular injection,3 doses |
| GSK Biologicals' DTPa-IPV/Hib vaccine | BIOLOGICAL | Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group |
| Prevenar | BIOLOGICAL | 3 Intramuscular injections |
| Polio Sabin. | BIOLOGICAL | 3 oral doses. |
| Poliorix. | BIOLOGICAL | 3 intramuscular injections |
Inclusion Criteria: * Male or female between, and including, 46-50 months of age at the time of vaccination. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * Subjects who previously participated in study NCT00333...
Pneumococcal conjugate vaccine GSK 1024850A is an investigational vaccine being studied for the prevention of infections caused by Streptococcus pneumoniae, including pneumonia, invasive disease, and acute otitis media. It is also being evaluated in the context of Hepatitis B. The vaccine is intended for use in infants and young children, with clinical trials enrolling participants as young as 6 weeks of age.
Pneumococcal conjugate vaccine GSK 1024850A is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. GSK is conducting Phase 3 clinical trials to evaluate the vaccine's safety, immunogenicity, and efficacy against pneumococcal infections.
Pneumococcal conjugate vaccine GSK 1024850A is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. GSK has completed eight Phase 3 trials with a total enrollment of 67,416 participants, all of which are now completed.
Pneumococcal conjugate vaccine GSK 1024850A has been studied in eight completed Phase 3 trials. Key trials include NCT00344318, a safety and immunogenicity study in 806 participants; NCT00466947, the COMPAS study evaluating efficacy against pneumonia and acute otitis media in 23,802 participants; NCT00861380, an effectiveness study against invasive disease in 41,188 participants; and NCT00907777, a booster study in 52 children.
Pneumococcal conjugate vaccine GSK 1024850A is a 10-valent pneumococcal conjugate vaccine developed by GSK. While it is often referred to by its development code, the vaccine is commercially known as Synflorix. The clinical trials listed under GSK 1024850A evaluate this 10-valent formulation for protection against pneumococcal disease.