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Phase 2 Completed N=951 Randomized Triple-blind Prevention

Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

Infections, Streptococcal
Source: ClinicalTrials.gov NCT01616459 ↗
Enrolled (actual)
951
Serious AEs
12.3%
Results posted
Jun 2014
Primary outcomePrimary: Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study — 1.54; 1.59; 1.37; 2.18 µg/mL

Summary

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.

Outcome Measures

OutcomeResultp-value
PRIMARY
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study
1.54; 1.59; 1.37; 2.18; 0.06; 0.06
PRIMARY
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes
99.5; 98.6; 97.7; 96.7; 100; 99.5
PRIMARY
Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype
98.6; 99.5
PRIMARY
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes
99.1; 98.6; 96.7; 96.7; 99.5; 99.5
PRIMARY
Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes
88.3; 99.5; 95.8; 99.5
SECONDARY
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study
0.26; 0.26; 0.26; 0.44; 2.49; 2.18
SECONDARY
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study
13.2; 15.6; 13.6; 26.4; 4.8; 5.2
SECONDARY
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study
192.4; 192.4; 216.8; 207.6; 9.7; 10.5
SECONDARY
Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study
1430.1; 1194.2; 1344.8; 64.4
SECONDARY
Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study
445.9; 447.6; 460.0; 70.9; 1866.0; 1835.5
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase
104; 105; 94; 85; 16; 5
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study
112; 123; 119; 110; 13; 16
SECONDARY
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study
148; 144; 129; 129; 7; 6
SECONDARY
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study
109; 100; 84; 96; 9; 6
SECONDARY
Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study
110; 108; 123; 124
SECONDARY
Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study
69; 68; 74; 53
SECONDARY
Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study
12; 11; 17; 12
SECONDARY
Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study
29; 26; 38; 24
SECONDARY
Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study
0.23; 0.89; 0.22; 0.64; 1.07; 7.94
SECONDARY
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study
1813.0; 1523.9; 759.6; 2056.6
SECONDARY
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study
4866.4; 3896.4; 2191.0; 5720.1
SECONDARY
Antibody Concentrations Against Pneumococcal Serotype 6C During the Primary Phase of the Study.
SECONDARY
Antibody Concentrations Against Pneumococcal Serotype 6C During the Booster Phase of the Study.
SECONDARY
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Primary Phase of the Study
SECONDARY
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Booster Phase of the Study

Eligibility Criteria

Inclusion Criteria

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
  • A male or female between, and including 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. In addition, the first pneumococcal and DTPa-HBV-IPV/Hib vaccination should be given in accordance with the official national recommendations for the immunisation schedule of infants.
  • Written informed consent obtained from the parents/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.

Exclusion Criteria

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine containing diphtheria toxoid, tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the following exceptions:
  • Licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines.
  • Licensed rotavirus vaccines are allowed if administered at least 7 days before or after each dose of study of vaccines.
  • Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly administered with the study vaccine at around 2, 4 and 12-15 months of age.
  • In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by the public health authorities, outside the routine immunization program, that vaccine can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations.
  • 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 .
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
  • History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during study period.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type b.
  • Previous vaccination against S. pneumoniae.
  • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b disease.
  • Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01616459). 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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