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.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00829010
First received: January 22, 2009
Last updated: October 22, 2015
Last verified: September 2015
  Purpose

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.

Condition Intervention Phase
Infections, Streptococcal
Biological: Pneumococcal vaccine GSK1024850A
Biological: Tritanrix-HepB/Hib
Biological: measles
Biological: Rotarix
Biological: Local OPV
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.


Secondary Outcome Measures:
  • Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. [ Time Frame: At Month 3 and Month 9 ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes. [ Time Frame: up to study end at Month 23 (24-27 months of age) ] [ Designated as safety issue: No ]
    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.

  • Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. [ Time Frame: At Month 3 and at Month 9 ] [ Designated as safety issue: No ]
    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.

  • Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes. [ Time Frame: up to study end at Month 23 (24-27 months of age) ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A. [ Time Frame: At Month 3 and Month 9 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. [ Time Frame: At Month 3 and at Month 9 ] [ Designated as safety issue: No ]
    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.

  • Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A. [ Time Frame: up to study end at Month 23 (24-27 months of age) ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Protein D (PD) by ELISA [ Time Frame: At Month 3 and at Month 9 ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Protein D (PD) by ELISA. [ Time Frame: up to study end at Month 23 (24-27 months of age) ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT). [ Time Frame: 1 month following primary immunization (at Month 3) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA. [ Time Frame: 1 month following primary immunization (at Month 3) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) [ Time Frame: 1 month following primary immunization (at Month 3) ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP) [ Time Frame: 1 month after the booster vaccination (at Month 15) ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA [ Time Frame: 1 month following primary immunization (at Month 3) ] [ Designated as safety issue: No ]

    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


  • 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) ] [ Designated as safety issue: No ]

    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


  • 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) ] [ Designated as safety issue: No ]
    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.

  • Concentrations of Antibodies Against Measles [ Time Frame: 1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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

  • 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) ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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.


  • Number of Subjects With Unsolicited AEs. [ Time Frame: Within the 31-day (Days 0-30) post-primary vaccination period ] [ Designated as safety issue: No ]
    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.

  • Number of Subjects With Unsolicited AEs. [ Time Frame: Within the 31-day (Days 0-30) post Synflorix booster vaccination period ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 489
Study Start Date: February 2009
Study Completion Date: August 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV+/+ Group
Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, administered as 3 or 4 doses
Biological: Tritanrix-HepB/Hib
Intramuscular injection, 4 doses
Other Name: DTPw-HBV/Hib
Biological: measles
Intramuscular injection, 2 doses
Biological: Rotarix
Oral, 2 doses
Other Names:
  • HRV
  • Human rotavirus
Biological: Local OPV
Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Other Name: oral poliovirus vaccine
Experimental: HIV+/- Group
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, administered as 3 or 4 doses
Biological: Tritanrix-HepB/Hib
Intramuscular injection, 4 doses
Other Name: DTPw-HBV/Hib
Biological: measles
Intramuscular injection, 2 doses
Biological: Rotarix
Oral, 2 doses
Other Names:
  • HRV
  • Human rotavirus
Biological: Local OPV
Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Other Name: oral poliovirus vaccine
Experimental: HIV- (3+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, administered as 3 or 4 doses
Biological: Tritanrix-HepB/Hib
Intramuscular injection, 4 doses
Other Name: DTPw-HBV/Hib
Biological: measles
Intramuscular injection, 2 doses
Biological: Rotarix
Oral, 2 doses
Other Names:
  • HRV
  • Human rotavirus
Biological: Local OPV
Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Other Name: oral poliovirus vaccine
Experimental: HIV- (EPI) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, administered as 3 or 4 doses
Biological: Tritanrix-HepB/Hib
Intramuscular injection, 4 doses
Other Name: DTPw-HBV/Hib
Biological: measles
Intramuscular injection, 2 doses
Biological: Rotarix
Oral, 2 doses
Other Names:
  • HRV
  • Human rotavirus
Biological: Local OPV
Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Other Name: oral poliovirus vaccine
Experimental: HIV- (2+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
Biological: Pneumococcal vaccine GSK1024850A
Intramuscular injection, administered as 3 or 4 doses
Biological: Tritanrix-HepB/Hib
Intramuscular injection, 4 doses
Other Name: DTPw-HBV/Hib
Biological: measles
Intramuscular injection, 2 doses
Biological: Rotarix
Oral, 2 doses
Other Names:
  • HRV
  • Human rotavirus
Biological: Local OPV
Oral 4 doses. Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
Other Name: oral poliovirus vaccine

Detailed Description:
This protocol posting has been updated according to Protocol amendment 1, December 08
  Eligibility

Ages Eligible for Study:   6 Weeks to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829010

Locations
South Africa
GSK Investigational Site
Soweto, Gauteng, South Africa, 2013
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00829010     History of Changes
Other Study ID Numbers: 111634 
Study First Received: January 22, 2009
Results First Received: May 8, 2012
Last Updated: October 22, 2015
Health Authority: South Africa: Medicines Control Council

Keywords provided by GlaxoSmithKline:
Human Immunodeficiency Virus
Booster vaccination
Safety
Primary vaccination
Pneumococcal vaccine
Immunogenicity
Pneumococcal disease

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Streptococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on February 07, 2016