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Also known as Synflorix (3-Dose), Synflorix™( GSK1024850A), Synflorix™ vaccine, Pneumococcal conjugate vaccine GSK1024850A, 10 valent pneumococcal conjugate (vaccine), Pneumococcal vaccine GSK1024850A, GSK1024805A, GSK's pneumococcal polysaccharide conjugate vaccine
Synflorix · 10 trials · 3 indications
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations \< 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per millilitre (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL. Antibody concentrations \< 0.05 μg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and were calculated, expressed as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations \< 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per millilitre (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 153 EL.U/mL. Antibody concentrations \< 153 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported.
The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented.
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 microgram per milliliter (µg/mL) as seropositivity cut off.
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme -linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the cut-off value. Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using 0.05 μg/mL as seropositivity cut off.
Fever was measured as rectal temperature. The cut-off was 39.0 degree Celsius (°C). Assessment of occurrences of fever \> 39.0 (°C) was performed after booster vaccination with Synflorix™ or Prevenar™ vaccines.
Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Concentrations were expressed as geometric mean concentration (GMC). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Concentrations were given as geometric mean concentration (GMC) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter.
Fever was measured as rectal temperature. Assessment of occurrences of rectal temperature \> 39.0 °C was performed post administration of the booster dose of pneumococcal vaccine (Synflorix™ or Prevenar™ vaccine) in this study. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available.
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The \>=0.20 microgram per milliliter (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microg/mL.
Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).
| Arm | Type | Description |
|---|---|---|
| At-risk-Unprimed Group | EXPERIMENTAL | Subjects who have not been previously vaccinated with any pneumococcal vaccine and are at an increased risk of pneumococcal infection. |
| At-risk-Primed Group | EXPERIMENTAL | Subjects who have been previously vaccinated * with at least one dose of a pneumococcal conjugate vaccine i.e. either Synflorix (10Pn-PD-DiT), Prevenar or Prevenar13. * with plain polysaccharide pneumococcal vaccine more than 2 years and less than 5 years before enrollment. and are at an increased risk of pneumococcal infection. |
| Healthy-Unprimed Group | ACTIVE_COMPARATOR | Subjects who have not been previously vaccinated with any pneumococcal vaccine and are healthy. |
| Healthy-Primed Group | ACTIVE_COMPARATOR | Subjects who have been previously vaccinated with at least one dose of a pneumococcal vaccine and are healthy. |
| Synflorix Group | ACTIVE_COMPARATOR | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. |
| Prevnar 1 Group | EXPERIMENTAL | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. |
| Prevnar 2 Group | EXPERIMENTAL | Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. |
| Control Group | ACTIVE_COMPARATOR | Subjects receiving Infanrix hexa™ vaccine alone. |
| Synflorix + Infanrix + Havrix and/or Varilrix Group | EXPERIMENTAL | This group consisted of subjects primed with Synflorix vaccine in the 10PN-PD-DIT-001 (1105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Synflorix vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose of Synflorix vaccine at 12-18 months of age co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix) and/or against varicella (a single dose of Varilrix). |
| Prevenar + Infanrix + Havrix and/or Varilrix Group | ACTIVE_COMPARATOR | This group consisted of subjects vaccinated with Prevenar vaccine in the 10PN-PD-DIT-001 (105553) and 007 (107046) studies. In 105553 study, subjects had been primed with 3 doses of Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In 107046 study, subjects had received a booster dose at 12-18 months of age of Prevenar vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 111347 study, subjects had received at Month 48 (4 years post Dose 1 in study 105553) one dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix). |
| Prevenar + Synflorix + Infanrix + Havrix and/or Varilrix | EXPERIMENTAL | This group consisted of subjects vaccinated with Prevenar and Synflorix vaccines in the 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046) studies. In 105553 study, subjects had been primed with 3 doses Prevenar vaccine at 2, 3 and 4 months of age co-administered with Infanrix related vaccines. In the 107046 study, subjects had received at 12-18 months of age a booster dose of Synflorix vaccine co-administered with Infanrix hexa vaccine. In this study, in the Year 4 (111347 study), subjects had received at Month 48 (4 years post Dose 1 in study 105553) one additional dose of Synflorix vaccine. In addition, subjects were also offered vaccination against hepatitis A (2 doses of Havrix and/or against varicella (a single dose of Varilrix). |
| Unprimed Group | EXPERIMENTAL | This group consisted of subjects between, and including, 64-68 months of age at the time of additional vaccination (primed subjects) or dose 1 (unprimed subjects), and for whom the investigator believed that their parents/guardians could and would comply with the requirements of the protocol. Subjects were not previously vaccinated with any pneumococcal vaccine and received 2 doses of Synflorix vaccine at 64-68 and 66-70 months of age (at Day 0 and Month 2). The Unprimed Group was added only in Year 4 of the study. |
| Synflorix + Tritanrix -HepB/ Hiberix + Polio Sabin Group | EXPERIMENTAL | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of Synflorix™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ vaccines at 12-18 months of age. |
| Prevenar + Tritanrix - HepB/ Hiberix + Polio Sabin Group | ACTIVE_COMPARATOR | Subjects in the Philippines, primary vaccinated at 6-10-14 weeks of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix™-HepB/ Hiberix™ and Polio Sabin™ at 12-18 months of age. |
| Synflorix + Tritanrix -HepB/ Hiberix + Poliorix Group | EXPERIMENTAL | Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of Synflorix™ vaccine co-administered with Tritanrix™-HepB/Hiberix™ and Poliorix™ vaccines at 12-18 months of age. |
| Prevenar + Tritanrix -HepB/ Hiberix + Poliorix Group | ACTIVE_COMPARATOR | Subjects in Poland, primary vaccinated at 2-4-6 months of age, receiving booster dose of the Prevenar™ vaccine, co-administered with Tritanrix -HepB/ Hiberix and Poliorix™ at 12-18 months of age. |
| Synflorix Vaccine Group | EXPERIMENTAL | Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age. |
| Synflorix-Synflorix Group | EXPERIMENTAL | This group consisted of subjects previously vaccinated with the Synflorix™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix™ vaccine at 2, 3 and 4 months of age (injected intramuscularly \[IM\] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. |
| Prevenar-Prevenar Group | ACTIVE_COMPARATOR | This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenar™ vaccine at 2, 3 and 4 months of age (injected intramuscularly \[IM\] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenar™ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. |
| Prevenar-Synflorix Group | EXPERIMENTAL | This group consisted of subjects previously vaccinated with the Prevenar™ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly \[IM\] in the right thigh) co-administered with Infanrix hexa™ vaccine, except for the second dose in France, which was co-administered with Infanrix™ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorix™, injected IM in the right thigh or deltoid, co-administered with Infanrix hexa™ vaccine, injected IM in the left thigh or deltoid. |
| Synflorix <6M Group | ACTIVE_COMPARATOR | This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate). |
| Synflorix 7-11M Group | EXPERIMENTAL | This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate). |
| Synflorix 12-23M Group | EXPERIMENTAL | This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate). |
| Synflorix >=24M Group | EXPERIMENTAL | This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children \>12 months of age if muscle size was adequate). |
| Synflorix Booster Group | EXPERIMENTAL | Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). |
| Synflorix Catch-up Group | EXPERIMENTAL | Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2). |
| Name | Type | Description |
|---|---|---|
| Synflorix™ | BIOLOGICAL | 1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh. |
| Synflorix (3-Dose) | BIOLOGICAL | 3 doses administered intramuscularly |
| Synflorix (2-Dose) | BIOLOGICAL | 2 doses administered intramuscularly |
| Synflorix (Single Dose) | BIOLOGICAL | 1 dose administered intramuscularly |
| Prevenar 13 (Single Dose) | BIOLOGICAL | 1 dose administered intramuscularly |
| Prevenar 13 (2-Dose) | BIOLOGICAL | 2 doses administered intramuscularly |
| Synflorix™( GSK1024850A) | BIOLOGICAL | Intramuscular, 3 doses |
| Infanrix hexa™ | BIOLOGICAL | Intramuscular, 3 doses |
| GSK1024805A | BIOLOGICAL | No vaccination in this trial |
| Prevenar | BIOLOGICAL | No vaccination in this trial |
| Infanrix hexa | BIOLOGICAL | No vaccination in this trial |
| Havrix | BIOLOGICAL | No vaccination in this trial |
| Varilrix | BIOLOGICAL | No vaccination in this trial |
| Synflorix | BIOLOGICAL | Intramuscular injection, 1 dose |
| Tritanrix-HepB | BIOLOGICAL | Intramuscular injection, 1 dose |
| Hiberix | BIOLOGICAL | Reconstituted with Tritanrix-Hep B before injection |
| Polio Sabin | BIOLOGICAL | Oral, 1 dose |
| Poliorix | BIOLOGICAL | Intramuscular injection, 1 dose |
| Prevenar (Wyeth) | BIOLOGICAL | Intramuscular injection, 1 dose |
| Rotarix | BIOLOGICAL | Oral, 2 doses. |
| Infanrix IPV/Hib | BIOLOGICAL | 4 intramuscular injections |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the s...
Synflorix is a pneumococcal vaccine studied for the prevention of infections caused by Streptococcus pneumoniae, including streptococcal infections. It has been evaluated in children, including healthy infants and children at increased risk of pneumococcal infection. Its clinical program also lists rotavirus among the infections studied.
Synflorix is developed by GSK plc, which trades under the ticker GSK. The vaccine appears in GSK's clinical development program under the identifier GSK1024850A, and the company has sponsored the Phase 3 studies conducted across multiple countries.
Synflorix has been studied in Phase 3 clinical development. Eight trials are listed for the vaccine, all of which are completed, with no active trials currently listed. The completed studies enrolled a total of 3,758 participants.
Synflorix has completed eight clinical trials, including NCT01746108 in children at increased risk of pneumococcal infection, NCT01641133 comparing primary vaccination with Synflorix or Prevenar 13, NCT01153841 in healthy infants in Vietnam, and NCT00547248, a booster study in children previously primed with the same vaccines.
Yes. Synflorix, Synflorix vaccine, Synflorix (3-Dose), and Synflorix (GSK1024850A) all refer to the same GSK pneumococcal vaccine. GSK1024850A is the company's internal identifier for the product, and the other names are alternate ways of referring to the same vaccine.