Approval Probability
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Also known as Pneumococcal conjugate vaccine GSK1024850A (different lots)
Pneumococcal conjugate vaccine GSK 1024850A · 10 trials · 8 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).
Concentrations are given as Geometric Mean Concentrations (GMCs) in microgram per milliliter (μg/mL). Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
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.
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 Clinical Lot & Infanrix Group | EXPERIMENTAL | Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1). |
| Synflorix Commercial Lot Infanrix Group | EXPERIMENTAL | Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1). |
| 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. |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™ | EXPERIMENTAL | Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age. |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™ | EXPERIMENTAL | Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age. |
| GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™ | EXPERIMENTAL | Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. |
| Prevenar™ + Menitorix™ | ACTIVE_COMPARATOR | Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age. |
| 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 (different lots) | BIOLOGICAL | Intramuscular injection, 3 doses |
| Infanrix hexa | BIOLOGICAL | Intramuscular injection, 3 doses in Malaysia and 2 doses in Singapore |
| Infanrix-IPV/Hib | BIOLOGICAL | Intramuscular injection, only for Visit 2 in Singapore |
| Rotarix | BIOLOGICAL | Oral, 2 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 |
| GSK Biologicals' DTPa-IPV/Hib vaccine | BIOLOGICAL | Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group |
| Prevenar | BIOLOGICAL | Intramuscular injection, 1 dose. |
| Infanrix IPV Hib | BIOLOGICAL | Intramuscular injection, 1 dose. In Spain. |
| Infanrix penta | BIOLOGICAL | Intramuscular injection, 1 dose. In Germany and Poland. |
| Infanrix IPV | BIOLOGICAL | Intramuscular injection, 1 dose. In Spain. |
| Meningitec | BIOLOGICAL | Intramuscular injection, 1 dose. |
| NeisVac-C | BIOLOGICAL | Intramuscular injection, 1 dose. |
| Menitorix | BIOLOGICAL | Intramuscular injection, 1 dose. |
| 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...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
Pneumococcal conjugate vaccine GSK 1024850A is an investigational vaccine developed by GSK plc for infectious disease indications, including streptococcal infections and Streptococcus pneumoniae disease. It is a conjugate vaccine studied primarily in healthy infants and children, with trial conditions also listing hepatitis B and infections. It remains in clinical development.
Pneumococcal conjugate vaccine GSK 1024850A is being studied for the prevention of streptococcal infections, including Streptococcus pneumoniae disease, in healthy infants and children. Trial conditions also list hepatitis B and general infections. It is an investigational vaccine and is not described as approved for any use.
Pneumococcal conjugate vaccine GSK 1024850A is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals conducted the clinical program for this pneumococcal conjugate vaccine candidate across multiple countries, including Finland, India, Germany, Malaysia and Singapore.
Pneumococcal conjugate vaccine GSK 1024850A is in Phase 3 development. Nine trials have been conducted in the program, all of which are completed, with no active trials currently listed. The vaccine is investigational and is not described as FDA approved.
The Phase 3 program includes NCT00861380, a large effectiveness study against invasive disease in Finland with 41,188 participants, plus NCT00907777 in Germany, NCT00814710 in India, and NCT00808444 in Malaysia and Singapore. All nine trials are completed, and total enrollment across the program is 67,882 participants.
Yes. Pneumococcal conjugate vaccine GSK 1024850A is also known as Pneumococcal conjugate vaccine GSK1024850A, including listings that distinguish different lots of the vaccine. These names refer to the same GSK plc pneumococcal conjugate vaccine candidate in Phase 3 development.