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Also known as DTPa-IPV
DTPa-IPV/Hib vaccine · 1 trial · 3 indications
A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).
A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.
Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.
Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations \< 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).
| Arm | Type | Description |
|---|---|---|
| Infanrix-IPV Group | EXPERIMENTAL | Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh. |
| Infanrix + IMOVAX Polio Group | ACTIVE_COMPARATOR | Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs. |
| Name | Type | Description |
|---|---|---|
| DTPa-IPV | BIOLOGICAL | 3 intramuscular injections |
| DTPa | BIOLOGICAL | 3 intramuscular injections |
| IMOVAX Polio® | BIOLOGICAL | 3 intramuscular injections |
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 obtain...
DTPa-IPV/Hib vaccine is a combined pediatric vaccine developed by GSK plc (ticker: GSK) for protection against tetanus, diphtheria, acellular pertussis, poliomyelitis, and Haemophilus influenzae type b disease. It is administered to healthy infants, with the first dose typically given from 8 weeks of age.
DTPa-IPV/Hib vaccine is used for active immunization of infants against tetanus, diphtheria, acellular pertussis, poliomyelitis, and Haemophilus influenzae type b. The Phase 3 trial NCT00290342 evaluated its immunogenicity, safety, and reactogenicity in healthy infants, with tetanus, acellular pertussis, and diphtheria listed as the studied conditions.
DTPa-IPV/Hib vaccine is developed and manufactured by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program for this combined pediatric vaccine.
DTPa-IPV/Hib vaccine is in Phase 3 clinical development. The program includes one completed Phase 3 trial, NCT00290342, which enrolled 458 healthy infants in South Korea. No active trials are currently listed for this vaccine.
DTPa-IPV/Hib vaccine has been evaluated in the Phase 3 trial NCT00290342, titled "Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants." The trial was completed, randomized, active-controlled, and enrolled 458 healthy infants aged 8 weeks and older in South Korea.