Infections, StreptococcalPhase 3NCT00829010
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.
A Phase 3 study testing Pneumococcal vaccine GSK1024850A, Tritanrix-HepB/Hib and measles in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in South Africa.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- Pneumococcal vaccine GSK1024850A, Tritanrix-HepB/Hib and measles
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 489 participants
- Where
- 1 siteSouth Africa
- Study dates
- 17 Feb 2009to 27 Jun 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This protocol posting has been updated according to Protocol amendment 1, December 08
- Conditions
- Infections, Streptococcal
- Being tested
- Pneumococcal vaccine GSK1024850A, Tritanrix-HepB/Hib, measles, Rotarix, Local OPV
- Keywords
- Human Immunodeficiency Virus, Booster vaccination, Safety, Primary vaccination, Pneumococcal vaccine, Immunogenicity, Pneumococcal disease
- Medical subject headings
- Streptococcal Infections, Acquired Immunodeficiency Syndrome, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal vaccine GSK1024850ABiological
Intramuscular injection, administered as 3 or 4 doses
Tritanrix-HepB/HibBiological
Also called DTPw-HBV/Hib
Intramuscular injection, 4 doses
measlesBiological
Intramuscular injection, 2 doses
RotarixBiological
Also called HRV, Human rotavirus
Oral, 2 doses
Local OPVBiological
Also called oral poliovirus vaccine
Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
| Study group | Role | What they receive |
|---|---|---|
| HIV+/+ Group | Experimental | 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. Receives: Biological: Pneumococcal vaccine GSK1024850A; Biological: Tritanrix-HepB/Hib; Biological: measles; Biological: Rotarix; Biological: Local OPV |
| HIV+/- Group | Experimental | 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. Receives: Biological: Pneumococcal vaccine GSK1024850A; Biological: Tritanrix-HepB/Hib; Biological: measles; Biological: Rotarix; Biological: Local OPV |
| HIV- (3+1) Group | Experimental | 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. Receives: Biological: Pneumococcal vaccine GSK1024850A; Biological: Tritanrix-HepB/Hib; Biological: measles; Biological: Rotarix; Biological: Local OPV |
| HIV- (EPI) Group | Experimental | 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. Receives: Biological: Pneumococcal vaccine GSK1024850A; Biological: Tritanrix-HepB/Hib; Biological: measles; Biological: Rotarix; Biological: Local OPV |
| HIV- (2+1) Group | Experimental | 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. Receives: Biological: Pneumococcal vaccine GSK1024850A; Biological: Tritanrix-HepB/Hib; Biological: measles; Biological: Rotarix; Biological: Local OPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: 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)
Secondary outcomes (30)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
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.
Measured: At Month 3 and Month 9
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
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.
Measured: up to study end at Month 23 (24-27 months of age)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
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.
Measured: At Month 3 and at Month 9
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
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.
Measured: up to study end at Month 23 (24-27 months of age)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
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.
Measured: At Month 3 and Month 9
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
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.
Measured: up to study end at Month 23 (24-27 months of age)
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
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.
Measured: At Month 3 and at Month 9
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
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.
Measured: up to study end at Month 23 (24-27 months of age)
Concentrations of Antibodies Against Protein D (PD) by ELISA
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.
Measured: At Month 3 and at Month 9
Concentrations of Antibodies Against Protein D (PD) by ELISA.
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.
Measured: up to study end at Month 23 (24-27 months of age)
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
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.
Measured: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
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.
Measured: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.
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.
Measured: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .
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.
Measured: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
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.
Measured: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
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.
Measured: 1 month after the booster vaccination (at Month 15)
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA
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
Measured: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.
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
Measured: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.
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.
Measured: 1 month after the administration of the second vaccine dose (at Month 3)
Concentrations of Antibodies Against Measles
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.
Measured: 1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
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.
Measured: up to study end at Month 23 (24-27 months of age)
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.
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
Measured: up to study end at Month 23 (24-27 months of age)
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
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
Measured: up to study end at Month 23 (24-27 months of age)
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
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.
Measured: During the 4-day (Days 0-3) post-primary vaccination period across doses
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
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.
Measured: During the 4-day (Days 0-3) post-primary vaccination period across doses
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
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.
Measured: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
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.
Measured: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Number of Subjects With Unsolicited AEs.
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.
Measured: Within the 31-day (Days 0-30) post-primary vaccination period
Number of Subjects With Unsolicited AEs.
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.
Measured: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Number of Subjects With Serious Adverse Events (SAEs).
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.
Measured: From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study start17 Feb 2009
- Primary completion13 Jun 2011
- Study completion27 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829010
- Sponsor's protocol ID
- 111634
- Status last verified
- Oct 2017
- First submitted
- 22 Jan 2009
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Izu A, Koen A, Jose L, Cutland C, de Gouveia L, von Gottberg A, Groome MJ, Jones S, Madhi SA. Persistence of Antibodies at Three, Four and Five Years of Age to Ten-valent Pneumococcal Polysaccharide Protein D-conjugate Vaccine in South African Children According to HIV Status. Pediatr Infect Dis J. 2026 Feb 1;45(2):173-180. doi: 10.1097/INF.0000000000005050. Epub 2025 Dec 3.
PubMed 41495936Nunes 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.
PubMed 33245004Madhi 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.
PubMed 32035706Madhi 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.
PubMed 28425818Madhi 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.
PubMed 28079828
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00829010
- Acronym / sponsor ID
- 111634
- Conditions
- Infections, Streptococcal
- Keywords
- Human Immunodeficiency Virus, Booster vaccination, Safety, Primary vaccination, Pneumococcal vaccine, Immunogenicity, Pneumococcal disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2009
- Primary completion
- 13 Jun 2011 (actual)
- Study completion
- 27 Jun 2012 (actual)
- First posted
- 26 Jan 2009 (estimated)
- Results
- Posted 6 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This protocol posting has been updated according to Protocol amendment 1, December 08
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HIV+/+ Group | Experimental | Biological: Pneumococcal vaccine GSK1024850A, Biological: Tritanrix-HepB/Hib, Biological: measles, Biological: Rotarix, Biological: Local OPVInfants 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. |
| HIV+/- Group | Experimental | Biological: Pneumococcal vaccine GSK1024850A, Biological: Tritanrix-HepB/Hib, Biological: measles, Biological: Rotarix, Biological: Local OPVInfants 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. |
| HIV- (3+1) Group | Experimental | Biological: Pneumococcal vaccine GSK1024850A, Biological: Tritanrix-HepB/Hib, Biological: measles, Biological: Rotarix, Biological: Local OPVInfants 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. |
| HIV- (EPI) Group | Experimental | Biological: Pneumococcal vaccine GSK1024850A, Biological: Tritanrix-HepB/Hib, Biological: measles, Biological: Rotarix, Biological: Local OPVInfants 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. |
| HIV- (2+1) Group | Experimental | Biological: Pneumococcal vaccine GSK1024850A, Biological: Tritanrix-HepB/Hib, Biological: measles, Biological: Rotarix, Biological: Local OPVInfants 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. |
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumococcal vaccine GSK1024850AIntramuscular injection, administered as 3 or 4 doses | Biological | HIV+/+ Group, HIV+/- Group, HIV- (2+1) Group, HIV- (3+1) Group, HIV- (EPI) Group |
| Tritanrix-HepB/HibAlso: DTPw-HBV/HibIntramuscular injection, 4 doses | Biological | HIV+/+ Group, HIV+/- Group, HIV- (2+1) Group, HIV- (3+1) Group, HIV- (EPI) Group |
| measlesIntramuscular injection, 2 doses | Biological | HIV+/+ Group, HIV+/- Group, HIV- (2+1) Group, HIV- (3+1) Group, HIV- (EPI) Group |
| RotarixAlso: HRV, Human rotavirusOral, 2 doses | Biological | HIV+/+ Group, HIV+/- Group, HIV- (2+1) Group, HIV- (3+1) Group, HIV- (EPI) Group |
| Local OPVAlso: oral poliovirus vaccineOral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine | Biological | HIV+/+ Group, HIV+/- Group, HIV- (2+1) Group, HIV- (3+1) Group, HIV- (EPI) Group |
Primary outcome
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
Time frame: 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)
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
30 secondary outcomes
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Time frame: At Month 3 and Month 9
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Time frame: up to study end at Month 23 (24-27 months of age)
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Time frame: At Month 3 and at Month 9
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
Time frame: up to study end at Month 23 (24-27 months of age)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Time frame: At Month 3 and Month 9
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Time frame: up to study end at Month 23 (24-27 months of age)
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Time frame: At Month 3 and at Month 9
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Time frame: up to study end at Month 23 (24-27 months of age)
Concentrations of Antibodies Against Protein D (PD) by ELISA
Time frame: At Month 3 and at Month 9
Concentrations of Antibodies Against Protein D (PD) by ELISA.
Time frame: up to study end at Month 23 (24-27 months of age)
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Time frame: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
Time frame: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.
Time frame: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .
Time frame: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
Time frame: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
Time frame: 1 month after the booster vaccination (at Month 15)
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA
Time frame: 1 month following primary immunization (at Month 3)
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.
Time frame: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.
Time frame: 1 month after the administration of the second vaccine dose (at Month 3)
Concentrations of Antibodies Against Measles
Time frame: 1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
Time frame: up to study end at Month 23 (24-27 months of age)
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.
Time frame: up to study end at Month 23 (24-27 months of age)
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
Time frame: up to study end at Month 23 (24-27 months of age)
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Time frame: During the 4-day (Days 0-3) post-primary vaccination period across doses
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Time frame: During the 4-day (Days 0-3) post-primary vaccination period across doses
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Time frame: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
Time frame: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
Number of Subjects With Unsolicited AEs.
Time frame: Within the 31-day (Days 0-30) post-primary vaccination period
Number of Subjects With Unsolicited AEs.
Time frame: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41495936Izu A, Koen A, Jose L, Cutland C, de Gouveia L, von Gottberg A, Groome MJ, Jones S, Madhi SA. Persistence of Antibodies at Three, Four and Five Years of Age to Ten-valent Pneumococcal Polysaccharide Protein D-conjugate Vaccine in South African Children According to HIV Status. Pediatr Infect Dis J. 2026 Feb 1;45(2):173-180. doi: 10.1097/INF.0000000000005050. Epub 2025 Dec 3.
- Derived from this study: PubMed 33245004Nunes 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.
- Derived from this study: PubMed 32035706Madhi 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.
- Derived from this study: PubMed 28425818Madhi 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.
- Derived from this study: PubMed 28079828Madhi 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pneumococcal vaccine GSK1024850A, Tritanrix-HepB/Hib and measles in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL). (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00829010, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.