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 julho de 2018 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This protocol posting has been updated according to Protocol amendment 1, December 08
Tipo de estudo
Intervencional
Inscrição (Real)
489
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Gauteng
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Soweto, Gauteng, África do Sul, 2013
- GSK Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
1 mês a 2 meses (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 doses
Outros nomes:
Injeção intramuscular, 4 doses
Outros nomes:
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
Outros nomes:
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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.
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Oral, 2 doses
Outros nomes:
Injeção intramuscular, 4 doses
Outros nomes:
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
Outros nomes:
|
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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 doses
Outros nomes:
Injeção intramuscular, 4 doses
Outros nomes:
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
Outros nomes:
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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 doses
Outros nomes:
Injeção intramuscular, 4 doses
Outros nomes:
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
Outros nomes:
|
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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 doses
Outros nomes:
Injeção intramuscular, 4 doses
Outros nomes:
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
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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).
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: up to study end at Month 23 (24-27 months of age)
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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 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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.
Prazo: 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).
Prazo: 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).
Prazo: 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.
Prazo: 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 .
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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.
Prazo: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
|
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.
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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
Prazo: 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).
Prazo: 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).
Prazo: 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).
Prazo: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
|
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).
Prazo: 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.
Prazo: 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.
Prazo: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
|
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).
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
17 de fevereiro de 2009
Conclusão Primária (Real)
13 de junho de 2011
Conclusão do estudo (Real)
27 de junho de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
22 de janeiro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de janeiro de 2009
Primeira postagem (Estimativa)
26 de janeiro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de agosto de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de julho de 2018
Última verificação
1 de outubro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 111634
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Dados/documentos do estudo
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Formulário de Relato de Caso Anotado
Identificador de informação: 111634Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Relatório de Estudo Clínico
Identificador de informação: 111634Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Protocolo de estudo
Identificador de informação: 111634Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Especificação do conjunto de dados
Identificador de informação: 111634Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Plano de Análise Estatística
Identificador de informação: 111634Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Conjunto de dados de participantes individuais
Identificador de informação: 111634Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
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Formulário de Consentimento Informado
Identificador de informação: 111634Comentários informativos: For additional information about this study please refer to the GSK Clinical Study Register
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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