Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00814710
First received: December 23, 2008
Last updated: February 6, 2014
Last verified: June 2012
  Purpose

The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of Indian infants with pneumococcal conjugate vaccine GSK1024850A co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine during the first 4 months of life. The study will be conducted in India.


Condition Intervention Phase
Infections, Streptococcal
Biological: Pneumococcal conjugate vaccine GSK1024850A
Biological: Tritanrix-HepB/Hib
Biological: Hiberix
Biological: Tritanrix-HepB
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]

    Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL).

    Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.


  • Concentration of Antibody Against Protein D (PD) [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]
    Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).


Secondary Outcome Measures:
  • Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]

    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

    Cross-reactive pneumococcal serotypes included 6A and 19A.

    Opsonophagocytic activity was defined 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 was an opsonic titer equal to or greater than 8.


  • Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value [ Time Frame: One month after primary immunization ] [ Designated as safety issue: No ]

    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

    The cut-off was defined as 0.20 microgram per milliliter (µg/mL).


  • Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]
    Concentrations were expressed as GMCs in µg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.

  • Number of Subjects Seropositive for Pneumococcal Serotypes [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]

    Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A.

    Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL


  • Number of Subjects Seropositive for Protein D (PD) [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]
    Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.

  • Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP) [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]
    Concentration is expressed as GMC in µg/mL.

  • Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT) [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]
    Concentrations were expressed as GMCs in international units per milliliter (IU/mL).

  • Concentration of Antibody Against Bordetella Pertussis (B. Pertussis) [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]
    Concentration was expressed as GMC in EL.U/mL.

  • Concentration of Antibody Against Hepatitis B (Anti-HBs) [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]
    Concentration was expressed as GMC in milli international units per milliliter (mIU/mL).

  • Number of Subjects Seropostive for B. Pertussis [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]
    Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.

  • Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs) [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]

    Seroprotection was defined as:

    Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.


  • Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL) [ Time Frame: One month after primary immunization (month 3) ] [ Designated as safety issue: No ]
    Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.

  • Number of Subjects With Solicited Local and General Symptoms [ Time Frame: Within 4 days (day 0-3) after vaccination ] [ Designated as safety issue: No ]
    Solicited local symptoms included pain, redness and swelling. Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: Within 31 days (day 0-30) after vaccination ] [ Designated as safety issue: No ]

    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Unsolicited AE covers any AE 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: Following first vaccination (Month 0) throughout the entire study period (month 3) ] [ Designated as safety issue: No ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.


Enrollment: 360
Study Start Date: March 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synflorix & Tritanrix-HebB/Hib Group
Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Biological: Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 3 doses
Biological: Tritanrix-HepB/Hib
Intramuscular injection, 3 doses
Other Name: DTPw-HBV/Hib
Active Comparator: Hiberix group & Tritanrix-HebB Group
Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
Biological: Hiberix
Intramuscular injection, 3 doses
Other Name: Hib
Biological: Tritanrix-HepB
Intramuscular injection, 3 doses
Other Name: DTPw-HBV

  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 or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
  • 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.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
  • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
  • History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus 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.
  • Major congenital defects or serious chronic illness.
  • Acute disease at the time of enrolment.
  • Babies for which birth weight is < 2 kilogram.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814710

Locations
India
GSK Investigational Site
Kolkata, India, 700073
GSK Investigational Site
Ludhiana, India, 141 008
GSK Investigational Site
Pune, India
GSK Investigational Site
Vellore, India, 632004
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00814710     History of Changes
Other Study ID Numbers: 111188
Study First Received: December 23, 2008
Results First Received: October 21, 2010
Last Updated: February 6, 2014
Health Authority: India: Ministry of Health

Keywords provided by GlaxoSmithKline:
Pneumococcal disease
Pneumococcal vaccine
Safety
Primary vaccination
Immunogenicity

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014