Phase 2
Completed N=284
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
| Outcome | Result | p-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
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.