Phase 3
N=806
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Infections, Streptococcal
Bottom Line
View on ClinicalTrials.gov: NCT00344318 ↗Enrolled (actual)
806
Serious AEs
11.3%
Results posted
Dec 2018
Primary outcome: Primary: Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) — 31; 6; 30; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pneumococcal conjugate vaccine GSK1024850A (Biological); Prevenar (Biological); Tritanrix-HepB (Biological); Hiberix (Biological); Polio Sabin. (Biological); Poliorix. (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) |
31; 6; 30; 13; 42; 8 | — |
| SECONDARY Number of Subjects With Any and Any Grade 3 Solicited Local Symptoms |
240; 206; 76; 65; 52; 59 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
154; 223; 45; 75; 6; 10 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
168; 166; 46; 61 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6; 34; 1; 9 | — |
| SECONDARY Number of Subjects With Serious Adverse (SAEs) |
16; 52; 4; 19 | — |
| SECONDARY Concentrations of Antibodies Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F |
3.23; 1.04; 0.03; 0.03; 4.96; 1.64 | — |
| SECONDARY Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.2 Microgram Per Milliliter (µg/mL) |
285; 280; 3; 3; 283; 282 | — |
| SECONDARY Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations Equal to or Above (≥) 0.05 Microgram Per Liter (µg/mL) |
285; 285; 20; 13; 285; 285 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F |
93.7; 14.8; 4.2; 4; 1008.7; 602.9 | — |
| SECONDARY Number of Subjects With Opsonophagocytic Activity (OPA) Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Equal to or Above (≥) 8 |
117; 62; 1; 0; 137; 143 | — |
| SECONDARY Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A |
0.3; 0.17; 0.23; 0.26; 0.36; 0.29 | — |
| SECONDARY Number of Subjects With Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 0.05 Microgram Per Milliliter (μg/mL) |
261; 230; 84; 84; 169; 164 | — |
| SECONDARY Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A |
93.1; 60.5; 137.3; 175.1; 10.6; 10.1 | — |
| SECONDARY Number of Subjects With Opsonophagocytic Activity (OPA) Against Cross-reactive Pneumococcal Serotypes 6A and 19A Equal to or Above (≥) 8 |
91; 83; 34; 36; 35; 41 | — |
| SECONDARY Concentrations of Antibodies Against Protein D (Anti-PD) |
3800; 2002; 105.2; 66.6 | — |
| SECONDARY Number of Subjects With Concentrations of Antibodies Against Protein D (Anti-PD) Equal to or Above (≥) 100 ELISA Units Per Milliliter (EL.U/mL) |
284; 285; 39; 18 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 0.15 Microgram Per Milliliter (µg/ mL) |
140; 140; 49; 47 | — |
| SECONDARY Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL) |
139; 137; 48; 45 | — |
| SECONDARY Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentrations |
26.001; 9.376; 25.758; 8.86 | — |
| SECONDARY Number of Subjects With Anti-diphtheria (Anti D) and Anti-tetanus Toxoids (Anti TT) Antibody Concentrations Equal to or Above 0.1 International Units Per Milliliter (IU/mL) |
137; 140; 49; 46; 139; 140 | — |
| SECONDARY Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations |
1.735; 1.549; 1.252; 1.039; 5.195; 3.505 | — |
| SECONDARY Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Equal to or Above 10 Milli-International Units Per Milliliter (mIU/mL) |
127; 132; 44; 44 | — |
| SECONDARY Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations |
101.6; 756.7; 129.8; 792.2 | — |
| SECONDARY Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Titers Equal to or Above (≥) 8 |
120; 120; 40; 40; 124; 115 | — |
| SECONDARY Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers |
641.5; 331.1; 373.7; 267.6; 523.6; 276.8 | — |
| SECONDARY Number of Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations Equal to or Above 15 ELISA Unit Per Milli-liter (EL.U/mL) (Seropositivity) |
137; 126; 47; 42 | — |
| SECONDARY Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations |
72.465; 53.481; 77.175; 60.003 | — |
| SECONDARY Number of Subjects With Vaccine Response to Bordetella Pertussis |
127; 112; 46; 38; 9; 12 | — |
Summary
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different schedules: 6-10-14 weeks or 2-4-6 months of age.
The study has 2 groups.
* One group of subjects will receive a 3-dose primary vaccination with the GSK Biologicals' pneumococcal conjugate vaccine (three different lots will be used and randomly allocated).
* The 2nd group of subjects will receive a 3-dose primary vaccination with Prevenar™.
All children will receive concomitantly DTPw-HBV/Hib and OPV or IPV vaccines. This protocol posting deals with objectives & outcome measures of the primary study. The objectives & outcome measures of the Booster study are presented in a separate protocol posting (NCT number =00547248).
Eligibility Criteria
Inclusion Criteria
- Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- 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.
- Born after a gestation period between 36 and 42 weeks.
Exclusion Criteria
- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations
- History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and 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 neurological disease.
- Acute disease at the time of enrolment
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the active phase of the study.
Data sourced from ClinicalTrials.gov (NCT00344318). 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.