Phase 3
N=452
Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants
Tetanus · Acellular Pertussis · Diphtheria
Bottom Line
View on ClinicalTrials.gov: NCT00290342 ↗Enrolled (actual)
452
Serious AEs
7.1%
Results posted
Oct 2018
Primary outcome: Primary: Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) — 204; 211; 204; 211 Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DTPa-IPV (Biological); DTPa (Biological); IMOVAX Polio® (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) |
0; 0; 194; 187; 1; 1 | — |
| PRIMARY Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3 |
204; 207; 204; 204; 203; 206 | — |
| PRIMARY Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA) |
200; 206; 201; 209; 202; 210 | — |
| PRIMARY Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens |
200; 206; 201; 209; 202; 210 | — |
| SECONDARY Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) |
0; 0; 194; 187; 1; 1 | — |
| SECONDARY Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T) |
0.052; 0.053; 4.333; 2.63; 0.059; 0.06 | — |
| SECONDARY Titers for Poliovirus Type 1, 2 and 3 Antibodies |
6.3; 6.1; 755.7; 263; 5.8; 6.5 | — |
| SECONDARY Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA) |
3; 3.2; 63.3; 55.6; 7.4; 8.5 | — |
| SECONDARY Number of Subjects Reporting Solicited Local Symptoms |
92; 96; 5; 8; 115; 116 | — |
| SECONDARY Number of Subjects Reporting Solicited General Symptoms |
95; 99; 4; 2; 54; 53 | — |
| SECONDARY Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) |
135; 138 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
15; 17 | — |
Summary
DTPa and IPV vaccines are recommended for immunization of infants in Korea. The use of combination vaccines simplifies routine paediatric vaccination. 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 .
- A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of 36 to 42 weeks inclusive.
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 since birth.
- Administration of any vaccine within 30 days (i.e.30 days to 1 day) before the first dose of the study vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the study period (i.e. Day 0 to Month 7), with the exception of Bacille Calmette-Guérin (BCG) vaccine, hepatitis B vaccine, pneumococcal vaccine, flu vaccine and Hib vaccine.
- Planned administration/ administration of a vaccine foreseen by the study protocol (i.e. BCG vaccine, hepatitis B vaccine, pneumococcal, flu vaccine and Hib vaccine) during the period 30 days before and one week after the study vaccine dose.
- 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 (pharmaceutical product or device).
- Previous vaccination against diphtheria, tetanus, pertussis and/or poliovirus disease.
- History of diphtheria, tetanus, pertussis and/or poliovirus diseases.
- Known exposure to diphtheria, tetanus, pertussis and/or poliovirus before the study period.
- Any anaemia/ thrombocytopenia or blood clot that leads to prohibition from intramuscular injection.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00290342). 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.