Phase 3
Completed N=984
Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine
Source: ClinicalTrials.gov NCT01086423 ↗Enrolled (actual)
984
Serious AEs
1.3%
Results posted
Apr 2017
Primary outcomePrimary: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens — 146; 156; 147; 147 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens |
146; 156; 147; 147; 156; 147 | — |
| PRIMARY Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen |
142; 155; 133 | — |
| PRIMARY Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens |
147; 157; 150; 147; 157; 150 | — |
| PRIMARY Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens |
147; 155; 147; 147; 155; 144 | — |
| SECONDARY Anti-D and Anti-T Antibody Concentrations |
0.052; 0.051; 0.051; 0.719; 0.753; 0.613 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
0.127; 0.135; 0.15; 5.601; 9.396; 2.826 | — |
| SECONDARY Anti-polio Types 1, 2 and 3 Antibody Titers |
9.4; 7.1; 9.2; 1143.7; 1328.9; 533.6 | — |
| SECONDARY Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations |
2.9; 2.7; 2.8; 108.7; 114.7; 97.1 | — |
| SECONDARY Number of Subjects With Any Solicited Local Symptoms |
65; 64; 83; 16; 19; 15 | — |
| SECONDARY Number of Subjects With Any Solicited General Symptoms |
95; 80; 69; 123; 120; 116 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
98; 114; 110 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
6; 3; 4 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
- Born after a gestation period of 36 to 42 weeks, inclusive.
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s) or LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Child in care.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B 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/or Haemophilus influenzae type b (Hib) disease or vaccination.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- Current febrile illness or axillary temperature > 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.
Data sourced from ClinicalTrials.gov (NCT01086423). 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. Informational only — not medical advice.