Last updated: 12/23/2020 04:10:07

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.

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GSK study ID
111634
See study documents
Clinicaltrials.gov ID
NCT00829010
See results summary
EudraCT ID
2011-002077-35
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).

Timeframe: 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:

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.

Timeframe: At Month 3 and Month 9

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.

Timeframe: up to study end at Month 23 (24-27 months of age)

Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.

Timeframe: At Month 3 and at Month 9

Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.

Timeframe: up to study end at Month 23 (24-27 months of age)

Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.

Timeframe: At Month 3 and Month 9

Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.

Timeframe: up to study end at Month 23 (24-27 months of age)

Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.

Timeframe: At Month 3 and at Month 9

Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.

Timeframe: up to study end at Month 23 (24-27 months of age)

Concentrations of Antibodies Against Protein D (PD) by ELISA

Timeframe: At Month 3 and at Month 9

Concentrations of Antibodies Against Protein D (PD) by ELISA.

Timeframe: up to study end at Month 23 (24-27 months of age)

Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).

Timeframe: 1 month following primary immunization (at Month 3)

Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).

Timeframe: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)

Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.

Timeframe: 1 month following primary immunization (at Month 3)

Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .

Timeframe: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)

Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)

Timeframe: 1 month following primary immunization (at Month 3)

Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)

Timeframe: 1 month after the booster vaccination (at Month 15)

Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA

Timeframe: 1 month following primary immunization (at Month 3)

Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.

Timeframe: 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.

Timeframe: 1 month after the administration of the second vaccine dose (at Month 3)

Concentrations of Antibodies Against Measles

Timeframe: 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

Timeframe: 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.

Timeframe: 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

Timeframe: 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).

Timeframe: 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).

Timeframe: 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).

Timeframe: 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).

Timeframe: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine

Number of Subjects With Unsolicited AEs.

Timeframe: Within the 31-day (Days 0-30) post-primary vaccination period

Number of Subjects With Unsolicited AEs.

Timeframe: Within the 31-day (Days 0-30) post Synflorix booster vaccination period

Number of Subjects With Serious Adverse Events (SAEs).

Timeframe: From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)

Interventions:
  • Biological/vaccine: Pneumococcal vaccine GSK1024850A
  • Biological/vaccine: Tritanrix-HepB/Hib
  • Biological/vaccine: measles
  • Biological/vaccine: Rotarix
  • Biological/vaccine: Local OPV
    • Enrollment:
    489
    Primary completion date:
    2011-13-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Madhi SA et al. (2017) 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. 16(6):641-656. doi: 10.1080/14760584.2017.1321990.
    Madhi SA et al. (2017) Vaccination with 10-valent pneumococcal conjugate vaccine in infants according to HIV status. Medicine. 96(2):e5881. doi: 10.1097/MD.0000000000005881.
    Nunes MC, Moreira M, Koen A, van Niekerk N, Jose L, Cutland CL, François N, Schoonbroodt S, Ruiz-Guiñazú 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 21;1-13. doi: 10.1080/14760584.2020.1853533. Online ahead of print.
    Medical condition
    Infections, Streptococcal
    Product
    GSK1024850A
    Collaborators
    Not applicable
    Study date(s)
    February 2009 to June 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 10 weeks
    Accepts healthy volunteers
    Yes
    • 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.
    • 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.
    Inclusion and exclusion 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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Soweto, Gauteng, South Africa, 2013
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2011-13-06
    Actual study completion date
    2012-27-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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