Phase 3
N=245
Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.
Infections, Streptococcal · Streptococcus Pneumoniae Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT00609492 ↗Enrolled (actual)
245
Serious AEs
1.6%
Results posted
Apr 2017
Primary outcome: Primary: Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) — 8; 6 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A) (Biological); Infanrix™-IPV/Hib (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Fever With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) |
8; 6 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
47; 67; 5; 4; 35; 65 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited General Symptoms |
21; 33; 1; 1; 34; 39 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
17; 24 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
3; 1 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
3; 1 | — |
| SECONDARY Number of Seropositive Subjects for Anti-pneumococcal Serotypes |
39; 56; 111; 43; 66; 119 | — |
| SECONDARY Number of Seroprotected Subjects Against Anti-pneumococcal Serotypes |
16; 28; 53; 43; 66; 118 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Serotypes |
0.15; 0.14; 0.17; 1.57; 1.74; 1.98 | — |
| SECONDARY Number of Seropositive Subjects for Pneumococcal Cross-reactive Serotypes 6A and 19A |
34; 51; 98; 41; 63; 115 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A |
0.12; 0.12; 0.14; 0.70; 0.77; 0.79 | — |
| SECONDARY Number of Seropositive Subjects for Protein D Antibodies (Anti-PD) |
39; 58; 114; 43; 66; 117 | — |
| SECONDARY Antibody Concentrations Against Protein D (Anti-PD) |
478.3; 340.0; 383.7; 1892.9; 1576.5; 1533.6 | — |
| SECONDARY Number of Seroprotected Subjects Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) |
20; 27; 51; 21; 34; 60 | — |
| SECONDARY Antibody Concentrations Against Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) |
0.381; 0.674; 0.481; 6.252; 9.982; 6.730 | — |
| SECONDARY Number of Seroprotected Subjects Against Anti-polyribosyl-ribitol Phosphate (Anti-PRP) |
16; 26; 50; 20; 34; 59 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ 1.0 µg/mL |
6; 9; 20; 20; 34; 59 | — |
| SECONDARY Antibody Concentrations Against Anti-polyribosyl-ribitol-phosphate (Anti-PRP) |
0.376; 0.509; 0.577; 33.731; 36.902; 38.713 | — |
| SECONDARY Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) |
10; 11; 30; 21; 34; 59 | — |
| SECONDARY Antibody Concentrations Against Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) |
5.7; 3.8; 5.5; 38.4; 32.7; 45.1 | — |
| SECONDARY Number of Subjects With Vaccine Response for Anti-PT, Anti-FHA and Anti-PRN Antibodies |
11; 21; 27; 9; 11; 24 | — |
| SECONDARY Number of Seroprotected Subjects Against Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) |
17; 22; 49; 3; 8; 20 | — |
| SECONDARY Antibody Titers Against Anti-polio Type 1, 2 and 3 |
52.3; 34.8; 54.7; 512.0; 1386.7; 1327.9 | — |
| SECONDARY Antibody Concentrations Against Anti-hepatitis B Surface Antigen (HBs) |
21.9; 117.2; 37.2 | — |
| SECONDARY Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes |
34; 49; 93; 35; 55; 100 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Against Pneumococcal Serotypes |
125; 143.6; 170.9; 971.8; 1307.2; 1479.3 | — |
| SECONDARY Number of Seropositive Subjects for Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A |
31; 45; 79; 23; 30; 56 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A |
270.6; 218.2; 207.4; 31.9; 41.4; 51.7 | — |
Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) in preterm born children at the age of 16-18 months. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number =NCT00390910 ). Subjects participating in this study should have received three doses of pneumococcal vaccine in the primary study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion Criteria
- 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.
- A male or female between, and including, 16-18 months of age at the time of the booster vaccination.
- A male or female who previously participated in study 107737 and received three doses of pneumococcal conjugate vaccine.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period (active phase and 5 months extended safety follow-up).
- Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting from one month (30 days) before the booster dose of study vaccines (Visit 1) and up to the follow-up visit (Visit 2).
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae other than the study vaccines from study 107737
- History of or intercurrent diphtheria, tetanus, hepatitis B, pertussis, polio, Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of seizures or progressive neurological disease
- Acute disease at the time of enrolment.
- Febrile illness defined as oral, axillary or tympanic temperature < 37.5°C / rectal temperature < 38°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins, with the exception of monoclonal antibodies against RSV, and/or any blood products within three months preceding the booster dose of study vaccines or planned administration during the active phase of the study.
Data sourced from ClinicalTrials.gov (NCT00609492). 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.