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Phase 2 Completed N=284 Randomized Prevention

Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants

Source: ClinicalTrials.gov NCT00871338 ↗
Enrolled (actual)
284
Serious AEs
5.3%
Results posted
Jul 2014
Primary outcomePrimary: Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP). — 108; 111 Participants

Summary

The purpose of this Phase II study is to evaluate the feasibility of GSK Biologicals' GSK2197870A vaccine co-administered with Wyeth-Lederle's Prevenar™ when given in healthy infants as a three-dose primary vaccination course at 2, 3 and 4 months of age followed by a booster dose of GSK Biologicals' Menitorix™ at 12 months of age.

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Seroprotected Subjects for Anti-polyribosylribitol Phosphate (Anti-PRP).
108; 111
PRIMARY
Number of Seropositive Subjects Against Neisseria Meningitidis Using Baby Rabbit Complement (rSBA-MenC)
104; 109; 101; 113
SECONDARY
Number of Subjects With Anti-PRP Concentrations Antibody Above the Cut-off.
96; 98
SECONDARY
Number of Subjects With Anti-polysaccharide C (Anti-PSC ) Antibody Concentrations Above the Cut-offs.
113; 115; 108; 114; 113; 113
SECONDARY
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
108; 119; 108; 119
SECONDARY
Number of Seropositive Subjects Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN).
107; 117; 106; 119; 108; 119
SECONDARY
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
89; 93; 88; 92; 89; 94
SECONDARY
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
47; 52; 14; 13; 46; 49
SECONDARY
Concentrations for Anti-PRP.
0.423; 0.574; 66.697; 26.899
SECONDARY
Titers for rSBA-MenC.
62.1; 67.1; 3062.9; 954.0
SECONDARY
Concentrations for Anti-PSC.
0.94; 0.87; 6.15; 2.88
SECONDARY
Concentrations for Anti-T and Anti-D.
0.428; 0.260; 0.249; 0.385; 0.015; 0.020
SECONDARY
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
7.3; 9.8; 35.3; 48.8; 15.0; 9.6
SECONDARY
Titers for Anti-polio 1, 2 and 3.
36.3; 18.8; 28.5; 24.5; 70.1; 50.7
SECONDARY
Concentrations for Anti-PNE Serotypes.
2.56; 2.18; 0.12; 0.12; 2.56; 1.85
SECONDARY
Number of Seroprotected Subjects for Anti-PRP.
76; 81; 98; 112
SECONDARY
Number of Seropositive Subjects Against rSBA-MenC.
70; 78; 93; 109
SECONDARY
Number of Subjects With Anti-PSC Antibody Concentrations Above the Cut-offs.
81; 89; 100; 111; 22; 14
SECONDARY
Number of Seroprotive Subjects for Anti-D and Anti-T Antibodies.
86; 87; 72; 94; 11; 3
SECONDARY
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
60; 88; 89; 98; 75; 72
SECONDARY
Number of Seroprotected Subjects for Anti-anti-polio Types 1, 2 and 3.
68; 62; 63; 69; 74; 76
SECONDARY
Concentrations for Anti-PRP.
0.423; 0.574; 66.697; 26.899
SECONDARY
Titers for rSBA-MenC.
62.1; 67.1; 3062.9; 954.0
SECONDARY
Concentrations for Anti-PSC.
0.94; 0.87; 6.15; 2.88
SECONDARY
Concentrations for Anti-T and Anti-D.
0.428; 0.260; 0.249; 0.385; 0.015; 0.020
SECONDARY
Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
7.3; 9.8; 35.3; 48.8; 15.0; 9.6
SECONDARY
Titers for Anti-polio 1, 2 and 3.
36.3; 18.8; 28.5; 24.5; 70.1; 50.7
SECONDARY
Number of Subjects With a Booster Response to rSBA-MenC Antibodies.
68; 61
SECONDARY
Number of Subjects With a Booster Response to Anti-PRP Antibodies.
75; 85
SECONDARY
Number of Subjects With a Booster Response to Anti-PSC Antibodies.
48; 27
SECONDARY
Number of Subjects Reporting Any Solicited Local Symptoms.
24; 11; 74; 56; 35; 20
SECONDARY
Number of Subjects Reporting Any Solicited General Symptoms.
43; 40; 75; 66; 41; 40
SECONDARY
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
75; 66
SECONDARY
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
9; 6

Eligibility Criteria

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:

  • A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination.
  • Born after 36 to 42 weeks of gestation.
  • Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

  • 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. For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration 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 .
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Hib, pneumococcal and/or group C meningococcal vaccination or disease.
  • History of seizures or progressive neurological disease (one episode of febrile convulsion does not constitute an exclusion criterion).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.

The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:

  • Current febrile illness or axillary temperature ≥37.5ºC or other moderate to severe illness within 24 hours of study vaccine administration
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00871338). 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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