Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.
11 de julio de 2018 actualizado por: GlaxoSmithKline
Primary and Booster Vaccination Course in Human Immunodeficiency Virus (HIV) Infected Infants, HIV Exposed Uninfected Infants and Unexposed Uninfected Infants Receiving the Pneumococcal Vaccine GSK 1024850A.
The purposes of this study:
- To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age and following booster vaccination at 9-10 months of age.
- To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at 6 and 14 weeks of age followed by booster vaccination at 9-10 months of age.
- This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all study participants.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This protocol posting has been updated according to Protocol amendment 1, December 08
Tipo de estudio
Intervencionista
Inscripción (Actual)
489
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Gauteng
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Soweto, Gauteng, Sudáfrica, 2013
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
1 mes a 2 meses (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
- A family history of hereditary immunodeficiency other than HIV infection.
- Major congenital defects or serious chronic illness other than HIV infection.
- For HIV infected infants: Moderately and severely symptomatic: stages III and IV according to latest version of WHO classification.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or Streptococcus pneumoniae.
- History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Acute disease at the time of enrolment.
- Babies for which weight for age is < 3rd percentile at Visit 1, using standard growth charts, with the exception of HIV infected infants for which the decision of enrolment was left to the investigator's discretion.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator.
- Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of vaccination).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: HIV+/+ Group
Infants born from a HIV positive mother and confirmed as HIV infected.
Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
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Oral, 2 dosis
Otros nombres:
Inyección intramuscular, 4 dosis
Otros nombres:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Otros nombres:
|
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Experimental: HIV+/- Group
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected.
Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
|
Oral, 2 dosis
Otros nombres:
Inyección intramuscular, 4 dosis
Otros nombres:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Otros nombres:
|
|
Experimental: HIV- (3+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.
Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
|
Oral, 2 dosis
Otros nombres:
Inyección intramuscular, 4 dosis
Otros nombres:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Otros nombres:
|
|
Experimental: HIV- (EPI) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
|
Oral, 2 dosis
Otros nombres:
Inyección intramuscular, 4 dosis
Otros nombres:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Otros nombres:
|
|
Experimental: HIV- (2+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
|
Oral, 2 dosis
Otros nombres:
Inyección intramuscular, 4 dosis
Otros nombres:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Periodo de tiempo: 1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)
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Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
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1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Periodo de tiempo: At Month 3 and Month 9
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Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups, post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
The cut-off of the assay is 0.05 µg/mL.
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At Month 3 and Month 9
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Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Periodo de tiempo: up to study end at Month 23 (24-27 months of age)
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Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
The cut-off of the assay is 0.05 µg/mL.
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up to study end at Month 23 (24-27 months of age)
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Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Periodo de tiempo: At Month 3 and at Month 9
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Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
The cut-off of the assay is an opsonic titer of 8.
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At Month 3 and at Month 9
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Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Periodo de tiempo: up to study end at Month 23 (24-27 months of age)
|
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
The cut-off of the assay is an opsonic titer of 8.
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up to study end at Month 23 (24-27 months of age)
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Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Periodo de tiempo: At Month 3 and Month 9
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Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations.
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
The cut-off of the assay is 0.05 µg/mL.
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At Month 3 and Month 9
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Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Periodo de tiempo: up to study end at Month 23 (24-27 months of age)
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Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations.
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
The cut-off of the assay is 0.05 µg/mL.
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up to study end at Month 23 (24-27 months of age)
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Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Periodo de tiempo: At Month 3 and at Month 9
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Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
The cut-off of the assay is an opsonic titer of 8.
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At Month 3 and at Month 9
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Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Periodo de tiempo: up to study end at Month 23 (24-27 months of age)
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Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
The cut-off of the assay is an opsonic titer of 8.
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up to study end at Month 23 (24-27 months of age)
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Concentrations of Antibodies Against Protein D (PD) by ELISA
Periodo de tiempo: At Month 3 and at Month 9
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Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL).
The cut-off of the assay was 100 EL.U/mL.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
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At Month 3 and at Month 9
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Concentrations of Antibodies Against Protein D (PD) by ELISA.
Periodo de tiempo: up to study end at Month 23 (24-27 months of age)
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Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL).
The cut-off of the assay was 100 EL.U/mL.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
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up to study end at Month 23 (24-27 months of age)
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Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Periodo de tiempo: 1 month following primary immunization (at Month 3)
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Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL) The cut-off of the assay is 0.1IU/mL.
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1 month following primary immunization (at Month 3)
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Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Periodo de tiempo: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
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Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL).
The cut-off of the assay is 0.1IU/mL.
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1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
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Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.
Periodo de tiempo: 1 month following primary immunization (at Month 3)
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Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL).
The cut-off of the assay is 15 EL.U/mL.
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1 month following primary immunization (at Month 3)
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Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .
Periodo de tiempo: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
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Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL).
The cut-off of the assay is 15 EL.U/mL.
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1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
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Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
Periodo de tiempo: 1 month following primary immunization (at Month 3)
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Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL).
The cut-off of the assay is 0.15 µg/mL.
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1 month following primary immunization (at Month 3)
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Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
Periodo de tiempo: 1 month after the booster vaccination (at Month 15)
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Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL).
The cut-off of the assay is 0.15 µg/mL.
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1 month after the booster vaccination (at Month 15)
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Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA
Periodo de tiempo: 1 month following primary immunization (at Month 3)
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Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay is 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis |
1 month following primary immunization (at Month 3)
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Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.
Periodo de tiempo: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
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Concentrations of antibodies were presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay was 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis |
1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
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Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.
Periodo de tiempo: 1 month after the administration of the second vaccine dose (at Month 3)
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Concentrations of antibodies are presented as GMCs expressed as units per millilitre (U/mL).
The cut-off of the assay is 20 U/mL.
Data were collected for subjects who received 1, 2 doses or no Rotarix dose during the study.
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1 month after the administration of the second vaccine dose (at Month 3)
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Concentrations of Antibodies Against Measles
Periodo de tiempo: 1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)
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Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL).The cut-off of the assay is 150 mIU/mL.
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1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)
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Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Periodo de tiempo: up to study end at Month 23 (24-27 months of age)
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Salivary antibodies against selected common bacterial protein antigens.
Salivary samples (1.0 mL) were collected by using an Oracol™ device consisting of a sponge (2 cm3) placed on a stick that was used to brush the teeth and gums to absorb the saliva.
Salivary samples were sent to RMPRU (or GSK Biologicals' designated validated laboratory) where the sponge was centrifuged to extract the saliva and that was immediately stored at -70°C.
The cut-off of the assay was 2.3 U/mL for anti-LytC IgA and 2.2 U/mL for anti PhtD IgA.
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up to study end at Month 23 (24-27 months of age)
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Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
Periodo de tiempo: up to study end at Month 23 (24-27 months of age)
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Positive cultures of H. influenza* (HI) and S. pneumonia(SP) and other bacterial pathogens such as Moraxella catarrhalis(MC), Group A streptococci and Staphylococcus aureus (SA), identified in the nasopharynx at each swab time point: Month (Mth) 0 (Pre-vaccination time point at 6-12 weeks of age), Mth 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age).
*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay
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up to study end at Month 23 (24-27 months of age)
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Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Periodo de tiempo: up to study end at Month 23 (24-27 months of age)
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Acquisition of new H. influenza* (HI) and S. pneumonia(SP) strains, identified in the nasopharynx at each swab time point: Month (Mth) 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age).
*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by PCR assay
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up to study end at Month 23 (24-27 months of age)
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Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Periodo de tiempo: During the 4-day (Days 0-3) post-primary vaccination period across doses
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Solicited local AEs assessed were pain, redness and swelling.
Any = incidence of any local symptom regardless of intensity grade.
Grade 3 pain = cried when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling above 30 millimetre.
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During the 4-day (Days 0-3) post-primary vaccination period across doses
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Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Periodo de tiempo: During the 4-day (Days 0-3) post-primary vaccination period across doses
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General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination. |
During the 4-day (Days 0-3) post-primary vaccination period across doses
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Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Periodo de tiempo: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
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Solicited local AEs assessed were pain, redness and swelling.
Any = incidence of any local symptom regardless of intensity grade.
Grade 3 pain = cried when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling above 30 millimetre.
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During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
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Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Periodo de tiempo: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
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Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination. |
During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
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Number of Subjects With Unsolicited AEs.
Periodo de tiempo: Within the 31-day (Days 0-30) post-primary vaccination period
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An unsolicited adverse event is any adverse event (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
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Within the 31-day (Days 0-30) post-primary vaccination period
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Number of Subjects With Unsolicited AEs.
Periodo de tiempo: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
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An unsolicited adverse event is any adverse event (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
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Within the 31-day (Days 0-30) post Synflorix booster vaccination period
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Number of Subjects With Serious Adverse Events (SAEs).
Periodo de tiempo: From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)
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SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
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From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Nunes MC, Moreira M, Koen A, van Niekerk N, Jose L, Cutland CL, Francois N, Schoonbroodt S, Ruiz-Guinazu J, Yarzabal JP, Borys D, Schuerman L, Madhi SA. Bacterial nasopharyngeal carriage following infant immunization with pneumococcal conjugate vaccines according to a 2+1 schedule in children in South Africa: an exploratory analysis of two clinical trials. Expert Rev Vaccines. 2020 Dec;19(12):1177-1189. doi: 10.1080/14760584.2020.1853533. Epub 2020 Dec 21.
- Madhi SA, Moreira M, Koen A, van Niekerk N, de Gouveia L, Jose L, Cutland CL, Francois N, Schoonbroodt S, Ruiz-Guinazu J, Yarzabal JP, Borys D, Schuerman L. Impact of HIV status and vaccination schedule on bacterial nasopharyngeal carriage following infant immunisation with the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in South Africa. Vaccine. 2020 Feb 28;38(10):2350-2360. doi: 10.1016/j.vaccine.2020.01.062. Epub 2020 Feb 5.
- Madhi SA, Koen A, Jose L, Moreira M, van Niekerk N, Cutland C, Francois N, Ruiz-Guinazu J, Yarzabal JP, Borys D, Schuerman L. Immunization with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) according to different schedules in infants in South Africa: a phase III trial. Expert Rev Vaccines. 2017 Jun;16(6):641-656. doi: 10.1080/14760584.2017.1321990.
- Madhi SA, Koen A, Jose L, van Niekerk N, Adrian PV, Cutland C, Francois N, Ruiz-Guinazu J, Yarzabal JP, Moreira M, Borys D, Schuerman L. Vaccination with 10-valent pneumococcal conjugate vaccine in infants according to HIV status. Medicine (Baltimore). 2017 Jan;96(2):e5881. doi: 10.1097/MD.0000000000005881.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
17 de febrero de 2009
Finalización primaria (Actual)
13 de junio de 2011
Finalización del estudio (Actual)
27 de junio de 2012
Fechas de registro del estudio
Enviado por primera vez
22 de enero de 2009
Primero enviado que cumplió con los criterios de control de calidad
22 de enero de 2009
Publicado por primera vez (Estimar)
26 de enero de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de agosto de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
11 de julio de 2018
Última verificación
1 de octubre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 111634
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Datos del estudio/Documentos
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Formulario de informe de caso anotado
Identificador de información: 111634Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Informe de estudio clínico
Identificador de información: 111634Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudio
Identificador de información: 111634Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Especificación del conjunto de datos
Identificador de información: 111634Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Plan de Análisis Estadístico
Identificador de información: 111634Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de datos de participantes individuales
Identificador de información: 111634Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
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Formulario de consentimiento informado
Identificador de información: 111634Comentarios de información: For additional information about this study please refer to the GSK Clinical Study Register
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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