Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00907777 | Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™ | PHASE3 | COMPLETED | 52 | — | — | Jun 23, 2009 | Oct 5, 2009 | Nov 23, 2020 | 17 | Germany |
| NCT00861380 | Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease | PHASE3 | COMPLETED | 41,188 | — | — | May 4, 2009 | Oct 5, 2013 | Dec 17, 2020 | 1 | Finland |
| NCT00814710 | Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age | PHASE3 | COMPLETED | 360 | — | — | Mar 7, 2009 | Nov 13, 2009 | Jan 3, 2020 | 4 | India |
| NCT00792909 | Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A | PHASE3 | COMPLETED | 172 | — | — | Dec 2, 2008 | Jul 2, 2009 | Dec 14, 2017 | 5 | Slovakia, Sweden |
| NCT00496015 | Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A | PHASE3 | COMPLETED | 750 | — | — | Jul 2, 2007 | Feb 17, 2009 | Jan 18, 2019 | 10 | Czechia |
| NCT00466947 | COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine | PHASE3 | COMPLETED | 23,802 | — | — | Jun 28, 2007 | Jul 28, 2011 | Jul 16, 2019 | 22 | Argentina, Colombia +1 |
| NCT00390910 | Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants | PHASE3 | COMPLETED | 286 | — | — | Oct 1, 2006 | May 2, 2008 | Dec 17, 2018 | 8 | Greece, Spain |
| NCT00344318 | Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine | PHASE3 | COMPLETED | 806 | — | — | Aug 7, 2006 | Oct 17, 2007 | Dec 7, 2018 | 7 | Philippines, Poland |
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...