Phase 3
N=756
Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT00547248 ↗Enrolled (actual)
756
Serious AEs
3.4%
Results posted
Jan 2019
Primary outcome: Primary: Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off — 64; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Synflorix (Biological); Tritanrix-HepB (Biological); Hiberix (Biological); Polio Sabin (Biological); Poliorix (Biological); Prevenar (Wyeth) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Rectal Temperature Greater Than (>) the Cut-off |
64; 20 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
203; 66; 248; 77; 40; 20 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited General Symptoms |
90; 32; 190; 66; 5; 1 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
25; 9; 106; 35 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
2; 0; 5; 2 | — |
| SECONDARY Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off |
135; 7; 122; 8; 136; 11 | — |
| SECONDARY Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations |
0.35; 0.03; 0.19; 0.04; 10.8; 0.04 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F |
13.2; 4.6; 8.5; 4.7; 1571.6; 4.9 | — |
| SECONDARY Antibody Concentrations to Protein D (Anti-PD) |
573.1; 136.8; 526.8; 73.8; 4973.9; 124.1 | — |
| SECONDARY Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A |
0.46; 0.24; 0.12; 0.13; 4.07; 4.57 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A |
113.6; 191.4; 46.8; 42.2; 882.8; 2563.8 | — |
| SECONDARY Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off |
135; 7; 122; 8; 136; 11 | — |
| SECONDARY Number of Subjects With Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F ≥ the Cut-off |
61; 3; 45; 3; 134; 5 | — |
| SECONDARY Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A ≥ the Cut-off |
128; 37; 105; 33; 133; 42 | — |
| SECONDARY Number of Subjects With Opsonophagocytic Activity (OPA) Against Pneumococcal Cross-reactive Serotypes 6A and 19A ≥ the Cut-off |
82; 30; 63; 19; 127; 43 | — |
| SECONDARY Number of Subjects With Antibody Concentrations Against Protein D (Anti-PD) ≥ the Cut-off |
131; 28; 117; 11; 135; 23 | — |
| SECONDARY Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations |
0.258; 0.17; 0.188; 0.126; 7.829; 4.768 | — |
| SECONDARY Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations |
5.335; 6.433; 1.03; 0.894; 106.004; 89.376 | — |
| SECONDARY Anti-Bordetella Pertussis (BPT) Antibody Concentrations |
12.88; 12.46; 9.54; 10; 139.51; 133.45 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations |
30; 23.4; 97.9; 113; 1220.5; 1098.1 | — |
| SECONDARY Anti-polio Type 1, 2 and 3 Antibody Titers |
329.1; 269; 46.5; 51.1; 854.6; 426.9 | — |
| SECONDARY Number of Subjects With Anti-Bordetella Pertussis (BPT) With Concentrations ≥ the Cut-off |
28; 10; 12; 7; 65; 25 | — |
| SECONDARY Number of Subjects With Anti-diphtheria (Anti-DT) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations ≥ the Cut-off |
56; 18; 49; 15; 65; 25 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration ≥ the Cut-off |
65; 25; 58; 23; 65; 25 | — |
| SECONDARY Number of Subjects With Anti-PRP Antibody Concentration ≥ the Cut-off |
56; 22; 32; 12; 65; 25 | — |
| SECONDARY Number of Subjects With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations ≥ the Cut-off |
53; 13; 63; 19; 68; 19 | — |
| SECONDARY Number of Subjects With Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers ≥ the Cut-off |
64; 19; 56; 19; 68; 19 | — |
| SECONDARY Number of Subjects With Vaccine Response to Anti-Bordetella Pertussis (BPT) |
37; 15; 48; 16; 27; 8 | — |
Summary
The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK 1024850A at 12 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, whole cell pertussis (DTPw)-combined vaccine and OPV or IPV vaccines. Subjects participating in this study should have received three doses of pneumococcal conjugate vaccine in the primary study.
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 = NCT00344318)
Eligibility Criteria
Inclusion Criteria
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 12-18 months of age at the time of the booster vaccination and who previously participated in study 107007 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 (pharmaceutical product or device).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines.
- Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit.
- Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b vaccine other than the study vaccines from study 107007.
- History of, or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b diseases.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
- Acute disease at the time of enrolment.
- 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 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 (NCT00547248). 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.