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Also known as Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
Pneumococcal conjugate vaccine Synflorix · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| 10Pn3+1-6W-6M/053 Group | EXPERIMENTAL | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) 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/053 Group | EXPERIMENTAL | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) 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. |
| Ctrl3+1-6W-6M/053 Group | ACTIVE_COMPARATOR | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV 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. |
| Ctrl2+1-6W-6M/053 Group | ACTIVE_COMPARATOR | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (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) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh. |
| 10Pn7-11M/053 Group | EXPERIMENTAL | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) 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) (7-11M 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/053 Group | ACTIVE_COMPARATOR | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) 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) (7-11M 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/053 Group | ACTIVE_COMPARATOR | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) 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/053 Group | EXPERIMENTAL | Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) 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. |
| Name | Type | Description |
|---|---|---|
| Pneumococcal conjugate vaccine Synflorix (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 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 only for children \>= 12 months of age at the time of first study vaccination. |
Inclusion Criteria: * Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study. * Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination. * Writt...
Pneumococcal conjugate vaccine Synflorix is a vaccine developed by GSK plc for streptococcal infections, including Streptococcus pneumoniae. It is a Phase 3 investigational product studied in a randomized, double-blind, active-controlled trial. The vaccine is designed to prevent infections caused by Streptococcus pneumoniae.
Pneumococcal conjugate vaccine Synflorix is being developed for the prevention of streptococcal infections, specifically those caused by Streptococcus pneumoniae. It is intended for use in healthy volunteers, with clinical study enrollment starting at 6 weeks of age. The vaccine targets infections that can lead to conditions such as acute otitis media.
Pneumococcal conjugate vaccine Synflorix is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical trial evaluating the vaccine. The vaccine is also identified by the code GSK1024850A.
Pneumococcal conjugate vaccine Synflorix is in Phase 3 clinical development. The Phase 3 trial has been completed, and no active trials are currently listed. It is an investigational vaccine and has not been approved by the FDA.
Pneumococcal conjugate vaccine Synflorix has been studied in one completed Phase 3 clinical trial, NCT00839254. The trial enrolled 6,181 participants in Finland and evaluated the impact on carriage, acute otitis media, immunogenicity, and safety. It was randomized, double-blind, and active-controlled.
Yes, Pneumococcal conjugate vaccine Synflorix is also known as GSK1024850A. GSK1024850A is the internal development code used by GSK plc for this vaccine. Both names refer to the same pneumococcal conjugate vaccine candidate.