Phase 3
N=451
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
Poliomyelitis · Tetanus · Acellular Pertussis · Diphtheria · Haemophilus Influenzae Type b
Bottom Line
View on ClinicalTrials.gov: NCT01309646 ↗Enrolled (actual)
451
Serious AEs
10.2%
Results posted
Apr 2013
Primary outcome: Primary: Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. — 213; 217; 213; 217 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Infanrix™-IPV+Hib (Biological); Infanrix™ IPV (Biological); Hiberix™ (Biological); Synflorix™ (Biological); Rotarix™ (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. |
29; 30; 64; 76 | — |
| PRIMARY Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3. |
212; 216; 204; 211; 197; 197 | — |
| PRIMARY Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. |
91; 109 | — |
| PRIMARY Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. |
54.2; 56; 125; 134.2; 125.8; 133.4 | — |
| SECONDARY Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN). |
213; 217; 213; 217; 213; 217 | — |
| SECONDARY Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations |
3.0; 3.1; 10.5; 11.7; 2.9; 3.1 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. |
29; 30; 64; 76 | — |
| SECONDARY Concentrations for Anti-D and Anti-T Antibodies. |
0.058; 0.060; 8.096; 8.692; 0.081; 0.091 | — |
| SECONDARY Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3. |
104; 89; 119; 108; 41; 31 | — |
| SECONDARY Titres for Anti-polio Types 1, 2 and 3. |
9.5; 9.4; 328.8; 372.7; 10.8; 8.8 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. |
91; 109 | — |
| SECONDARY Concentrations of Anti-PRP Antibodies. |
0.165; 0.219; 8.456; 18.700 | — |
| SECONDARY Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN. |
211; 215; 207; 207; 213; 216 | — |
| SECONDARY Number of Subjects With Any Solicited Local Symptoms. |
143; 146; 177; 167; 130; 121 | — |
| SECONDARY Number of Subjects With Any Solicited General Symptoms. |
153; 147; 181; 182; 120; 103 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs). |
130; 123 | — |
| SECONDARY Number of Subjects With Any Serious Adverse Events (SAEs). |
25; 21 | — |
Summary
This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
Eligibility Criteria
Inclusion Criteria
- A male or female between, and including, 42 and 69 days of age at the time of the first vaccination.
- Born after a gestation period of 37 to 42 weeks inclusive.
- Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine.
- 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, poliomyelitis and Hib vaccination or disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurological disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment.
Data sourced from ClinicalTrials.gov (NCT01309646). 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.