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Phase 3 Completed N=466 Randomized Double-blind Prevention

Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age

Infections, Streptococcal
Source: ClinicalTrials.gov NCT00808444 ↗
Enrolled (actual)
466
Serious AEs
5.4%
Results posted
Nov 2010
Primary outcomePrimary: Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine — 2.67; 2.46; 3.95; 3.14 μg/mL

Summary

The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.

Outcome Measures

OutcomeResultp-value
PRIMARY
Concentrations of Antibodies Against Vaccine Components of the Pneumococcal Vaccine
2.67; 2.46; 3.95; 3.14; 4.34; 3.59
PRIMARY
Concentration of Antibody Against Protein D (PD)
2543.6; 1869.8
SECONDARY
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 µg/mL
219; 218; 219; 218; 218; 218
SECONDARY
Number of Subjects With Anti-pneumococcal Cross-reactive Serotype Concentrations Equal to or Above 0.20 µg/mL
152; 132; 135; 119
SECONDARY
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
185; 189; 207; 203; 204; 203
SECONDARY
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes
173; 171; 83; 75
SECONDARY
Opsonophagocytic Titers of Cross-reactive Pneumococcal Serotypes
230.8; 173.7; 18.1; 15.1
SECONDARY
Poliovirus Types 1, 2 and 3 Titers
313.8; 328.7; 278.7; 229.1; 408.8; 449.4
SECONDARY
Concentrations of Antibodies Against Diphteria Toxoid (DT) and Tetanus Toxoid (TT)
3.317; 3.353; 4.879; 4.476
SECONDARY
Concentration of Antibody Against Hepatitis B Surface Antigen (HBs) by Enzyme Linked ImmunoSorbent Assay (ELISA).
1521.2; 2114.1
SECONDARY
Concentration of Antibody Against Rotavirus Immunoglobulin A (IgA)
141.1; 114.8
SECONDARY
Occurrence of Serious Adverse Events
18; 7
SECONDARY
Opsonophagocytic Titers of Vaccine Pneumococcal Serotypes
128.9; 122.1; 698.3; 609.3; 127.9; 98.6
SECONDARY
Number of Subjects With Solicited Local and General Symptoms.
162; 157; 149; 142; 133; 124
SECONDARY
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA), Pertactin (PRN)
46.5; 45.4; 179.2; 186.2; 142.1; 128.3
SECONDARY
Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
9.745; 6.387
SECONDARY
Occurrence of Unsolicited Adverse Events
88; 96

Eligibility Criteria

Inclusion Criteria

  • Male or female subjects between, and including 6-12 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.
  • Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
  • Born after a gestation period of >= 36 to <= 42 weeks.

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.
  • 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, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
  • History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus 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.
  • Gastroenteritis within 7 days preceding the study vaccine administration.
  • Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00808444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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