Phase 3
N=660
Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
Tetanus · Diphtheria · Acellular Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT00412854 ↗Enrolled (actual)
660
Serious AEs
1.7%
Results posted
Feb 2017
Primary outcome: Primary: Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) — 162; 164; 163; 164 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Infanrix™/Hib (Biological); Infanrix (Biological); Hiberix (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T) |
162; 164; 163; 164 | — |
| PRIMARY Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) |
158; 164 | — |
| PRIMARY Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies |
163; 164; 163; 164; 159; 162 | — |
| SECONDARY Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL |
145; 156 | — |
| SECONDARY Concentrations for Anti-D and Anti-T Antibodies |
0.050; 0.051; 0.545; 0.567; 0.050; 0.050 | — |
| SECONDARY Concentrations for Anti-PRP Antibodies |
0.083; 0.083; 3.559; 6.120 | — |
| SECONDARY Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies |
66.0; 67.0; 207.2; 198.1; 172.4; 177.5 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
44; 46; 2; 3; 5; 11 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
71; 84; 0; 3; 59; 72 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
171; 189 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
4; 7 | — |
Summary
This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.
Eligibility Criteria
Inclusion Criteria
- A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
- written informed consent obtained from the parent or guardian of the subject
Exclusion Criteria
- Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
- Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.
Data sourced from ClinicalTrials.gov (NCT00412854). 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.