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

GlaxoSmithKline1 site in 1 country360 target enrollmentMarch 7, 2009

ConditionsInfections, Streptococcal Streptococcus Pneumoniae

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infections, Streptococcal
Sponsor: GlaxoSmithKline
Enrollment: 360
Locations: 1
Primary Endpoint: Concentration of Antibody Against Protein D (PD)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 7, 2009

End Date

November 13, 2009

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

Concentration of Antibody Against Protein D (PD)

Time Frame: One month after primary immunization (month 3)

Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes

Time Frame: One month after primary immunization (month 3)

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.

Secondary Outcomes

Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes(One month after primary immunization (month 3))
Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)(One month after primary immunization (month 3))
Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).(One month after primary immunization (month 3))
Number of Subjects Seropositive for Protein D (PD)(One month after primary immunization (month 3))
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)(One month after primary immunization (month 3))
Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)(One month after primary immunization (month 3))
Number of Subjects Seropostive for B. Pertussis(One month after primary immunization (month 3))
Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)(One month after primary immunization (month 3))
Number of Subjects Seropositive for Pneumococcal Serotypes(One month after primary immunization (month 3))
Number of Subjects With Serious Adverse Events (SAEs)(Following first vaccination (Month 0) throughout the entire study period (month 3))
Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes(One month after primary immunization (month 3))
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value(One month after primary immunization)
Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)(One month after primary immunization (month 3))
Number of Subjects With Solicited Local and General Symptoms(Within 4 days (day 0-3) after vaccination)
Number of Subjects With Unsolicited Adverse Events (AEs)(Within 31 days (day 0-30) after vaccination)