Phase 2
Completed N=421
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
Source: ClinicalTrials.gov NCT00970307 ↗Enrolled (actual)
421
Serious AEs
3.3%
Results posted
Apr 2017
Primary outcomePrimary: Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) — 126; 123; 130 Participants
Summary
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP) |
126; 123; 130 | — |
| PRIMARY Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC) |
124; 127; 10 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
0.197; 0.152; 0.176; 4.255; 1.123; 1.721 | — |
| SECONDARY Antibody Titers Against rSBA-MenC |
4.3; 4.8; 4.2; 786.9; 2674; 6.1 | — |
| SECONDARY Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC) |
124; 125; 8 | — |
| SECONDARY Anti-PSC Antibody Concentrations |
0.17; 0.17; 0.18; 19.15; 18.1; 0.19 | — |
| SECONDARY Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) |
126; 132; 132; 126; 132; 132 | — |
| SECONDARY Anti-D and Anti-T Antibody Concentrations |
1.671; 1.437; 1.421; 3.966; 1.595; 2.458 | — |
| SECONDARY Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) |
127; 132; 132; 127; 131; 132 | — |
| SECONDARY Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations |
3.5; 3.6; 3.8; 36.1; 41.7; 37.6 | — |
| SECONDARY Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN |
121; 124; 122; 116; 123; 120 | — |
| SECONDARY Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs) |
116; 124; 122; 116; 124; 122 | — |
| SECONDARY Anti-HBs Antibody Concentrations |
1001.4; 1187.7; 1073.2 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3 |
91; 103; 92; 90; 101; 91 | — |
| SECONDARY Anti-polio Types 1, 2 and 3 Antibody Titers |
132.3; 156.7; 126.2; 97.4; 104.3; 95.8 | — |
| SECONDARY Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes |
125; 37; 124; 122; 21; 127 | — |
| SECONDARY Anti-pneumo Antibody Concentrations |
1.53; 0.04; 1.41; 1.92; 0.04; 1.99 | — |
| SECONDARY Number of Seropositive Subjects for Anti-protein D (Anti-PD) |
126; 18; 130 | — |
| SECONDARY Anti-PD Antibody Concentrations |
1622.8; 63.3; 1561.6 | — |
| SECONDARY Number of Subjects With Any Solicited Local Symptoms |
66; 70; 85; 83; 81; 83 | — |
| SECONDARY Number of Subjects With Any Solicited General Symptoms |
105; 91; 107; 108; 101; 113 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
61; 52; 61 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
5; 6; 3 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination.
- Born after a gestation period of 36 to 42 weeks inclusive.
- Subjects should have received one dose of hepatitis B vaccination at birth as per local recommendations.
- Subjects who the investigator believes that their parent(s)/LAR can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent/LAR of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Use of any investigational or non-registered product other than the study vaccines 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.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of any vaccine since birth, with exception of HBV and Bacillus Calmette-Guérin, 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, hepatitis B, polio, Hib, pneumococcal and/or MenC disease.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- 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 if no other exclusion criteria is met:
- Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Data sourced from ClinicalTrials.gov (NCT00970307). 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.