Phase 3
Completed N=50
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
Source: ClinicalTrials.gov NCT00964028 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Number of Subjects With Any Solicited Local Symptoms — 4; 2; 2; 0 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 This can indicate results are unpublished — a known publication-bias signal.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
This study will evaluate the safety and reactogenicity of Infanrix-IPV/Hib given as a three-dose primary vaccination course to healthy infants at 2-3-4 or 3-4-5 months of age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any Solicited Local Symptoms |
4; 2; 2; 0; 1; 0 | — |
| PRIMARY Number of Subjects With Any Solicited General Symptoms |
9; 1; 9; 5; 7; 1 | — |
| PRIMARY Number of Subjects With Unsolicited Adverse Events (AEs) |
16; 1 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0 | — |
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 parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- 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.
Exclusion Criteria
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- 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 Hib disease.
- Previous vaccination against diphtheria, tetanus, pertussis, poliovirus and/or Haemophilus influenzae type b diseases.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- 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 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Data sourced from ClinicalTrials.gov (NCT00964028). 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.