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.
keskiviikko 11. heinäkuuta 2018 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Ehdot
Yksityiskohtainen kuvaus
This protocol posting has been updated according to Protocol amendment 1, December 08
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
489
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
Gauteng
-
Soweto, Gauteng, Etelä-Afrikka, 2013
- GSK Investigational Site
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
1 kuukausi - 2 kuukautta (Lapsi)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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).
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
Suun kautta, 2 annosta
Muut nimet:
Lihaksensisäinen injektio, 4 annosta
Muut nimet:
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
Muut nimet:
|
|
Kokeellinen: 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.
|
Suun kautta, 2 annosta
Muut nimet:
Lihaksensisäinen injektio, 4 annosta
Muut nimet:
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
Muut nimet:
|
|
Kokeellinen: 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.
|
Suun kautta, 2 annosta
Muut nimet:
Lihaksensisäinen injektio, 4 annosta
Muut nimet:
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
Muut nimet:
|
|
Kokeellinen: 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.
|
Suun kautta, 2 annosta
Muut nimet:
Lihaksensisäinen injektio, 4 annosta
Muut nimet:
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
Muut nimet:
|
|
Kokeellinen: 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.
|
Suun kautta, 2 annosta
Muut nimet:
Lihaksensisäinen injektio, 4 annosta
Muut nimet:
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
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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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).
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Aikaikkuna: At Month 3 and Month 9
|
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.
|
At Month 3 and Month 9
|
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Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Aikaikkuna: up to study end at Month 23 (24-27 months of age)
|
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.
|
up to study end at Month 23 (24-27 months of age)
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Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Aikaikkuna: At Month 3 and at Month 9
|
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.
|
At Month 3 and at Month 9
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Aikaikkuna: 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.
|
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.
Aikaikkuna: At Month 3 and Month 9
|
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.
|
At Month 3 and Month 9
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Aikaikkuna: up to study end at Month 23 (24-27 months of age)
|
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.
|
up to study end at Month 23 (24-27 months of age)
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Aikaikkuna: At Month 3 and at Month 9
|
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.
|
At Month 3 and at Month 9
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Aikaikkuna: up to study end at Month 23 (24-27 months of age)
|
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.
|
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
Aikaikkuna: At Month 3 and at Month 9
|
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.
|
At Month 3 and at Month 9
|
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Concentrations of Antibodies Against Protein D (PD) by ELISA.
Aikaikkuna: up to study end at Month 23 (24-27 months of age)
|
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).
Aikaikkuna: 1 month following primary immunization (at Month 3)
|
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).
Aikaikkuna: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
|
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.
Aikaikkuna: 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.
|
1 month following primary immunization (at Month 3)
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Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .
Aikaikkuna: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
|
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)
Aikaikkuna: 1 month following primary immunization (at Month 3)
|
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.
|
1 month following primary immunization (at Month 3)
|
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Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
Aikaikkuna: 1 month after the booster vaccination (at Month 15)
|
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.
|
1 month after the booster vaccination (at Month 15)
|
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Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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
Aikaikkuna: 1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)
|
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
Aikaikkuna: 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.
Aikaikkuna: up to study end at Month 23 (24-27 months of age)
|
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
Aikaikkuna: 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
|
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).
Aikaikkuna: During the 4-day (Days 0-3) post-primary vaccination period across doses
|
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).
Aikaikkuna: 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).
Aikaikkuna: 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.
|
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).
Aikaikkuna: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
|
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
|
|
Number of Subjects With Unsolicited AEs.
Aikaikkuna: Within the 31-day (Days 0-30) post-primary 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.
|
Within the 31-day (Days 0-30) post-primary vaccination period
|
|
Number of Subjects With Unsolicited AEs.
Aikaikkuna: 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.
|
Within the 31-day (Days 0-30) post Synflorix booster vaccination period
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Number of Subjects With Serious Adverse Events (SAEs).
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 17. helmikuuta 2009
Ensisijainen valmistuminen (Todellinen)
Maanantai 13. kesäkuuta 2011
Opintojen valmistuminen (Todellinen)
Keskiviikko 27. kesäkuuta 2012
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 22. tammikuuta 2009
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 22. tammikuuta 2009
Ensimmäinen Lähetetty (Arvio)
Maanantai 26. tammikuuta 2009
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 17. elokuuta 2018
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 11. heinäkuuta 2018
Viimeksi vahvistettu
Sunnuntai 1. lokakuuta 2017
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 111634
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Tutkimustiedot/asiakirjat
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Selosteilla varustettu tapausraporttilomake
Tiedon tunniste: 111634Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Kliinisen tutkimuksen raportti
Tiedon tunniste: 111634Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Tutkimuspöytäkirja
Tiedon tunniste: 111634Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Tietojoukon määritys
Tiedon tunniste: 111634Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Tilastollinen analyysisuunnitelma
Tiedon tunniste: 111634Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Yksittäisen osallistujan tietojoukko
Tiedon tunniste: 111634Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
-
Ilmoitettu suostumuslomake
Tiedon tunniste: 111634Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Infektiot, streptokokki
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Bactiguard ABKarolinska University HospitalValmisLeikkaus | Central Line Associated Blood Stream Infections (CLABSI)Ruotsi
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Rabin Medical CenterRekrytointiCentral-line Associated Blood Stream Infections (CLABSI)Israel
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Emory UniversityValmisCentral Line Associated Bloodstream Infections (CLABSI) | LuuydinsiirtoYhdysvallat
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Swedish Medical CenterProvidence Health & ServicesRekrytointiCentral Line Associated Blood Stream Infections (CLABSI)Yhdysvallat
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CorMedixRekrytointiCentral Line Associated Blood Stream Infections (CLABSI)Yhdysvallat, Turkki (Türkiye)
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Hiroshima UniversityEi vielä rekrytointiaHengityslaitteen hankittu keuhkokuume | Central Line Associated Blood Stream Infections (CLABSI) | Painehaava (PU) | Lääkinnällisen laitteen aiheuttama painohaava (MDRPU)Bangladesh, Japani
Kliiniset tutkimukset Rotarix
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University of VermontInternational Centre for Diarrhoeal Disease Research, Bangladesh; Thrasher... ja muut yhteistyökumppanitValmisRotavirusinfektio | Rokotevaste heikentynyt | Rokote Viruksen leviäminenBangladesh
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GlaxoSmithKlineValmisInfektiot, rotavirusKorean tasavalta
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Telethon Kids InstituteMenzies School of Health ResearchAktiivinen, ei rekrytointiRotaviruksesta johtuva virusperäinen gastroenteriittiAustralia
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GlaxoSmithKlineValmis
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GlaxoSmithKlineValmis
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Seattle Children's HospitalNational Center for Research Resources (NCRR); Thrasher Research FundValmisSuoliston vajaatoiminta | RotavirusrokotteetYhdysvallat
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Oxford University Clinical Research Unit, VietnamChildren's Hospital Number 1, Ho Chi Minh City, Vietnam; Hospital for Tropical... ja muut yhteistyökumppanitValmisRipuli | RotavirusVietnam