Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants

Browse trials for

• Poliomyelitis 222

Keywords

• IPV

Poliomyelitis

222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.

This study's enrollment of 25 is below the median of 456 across 199 interventional studies indexed under Poliomyelitis.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Experimental
  IPV Group

  Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, receive 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.

  Biological: Poliorix

Interventions

• BiologicalPoliorix

  All subjects receive three doses of Poliorix vaccine, administered intramuscularly into the upper right side of the thigh.

Primary outcomes

1. Number of Subjects Reporting Solicited Local Symptoms

   Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site.

   Time frame: During the 4-day follow-up period after each dose of study vaccine.

2. Number of Subjects Reporting Solicited General Symptoms

   Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade of relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 fever = fever above (\>) 39.0°C. Related = symptom assessed by the investigator as related to vaccination.

   Time frame: During the 4-day follow-up period after each dose of study vaccine.

3. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

   Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

   Time frame: During the 31-days follow-up period after each dose of the study vaccine.

4. Number of Subjects Reporting Serious Adverse Events (SAEs)

   SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

   Time frame: During the entire study period (from Dose 1 up to one month following last vaccine dose).

Baseline characteristics

Publications

• Li R, Li CG, Li Y, Liu Y, Zhao H, Chen X, Kuriyakose S, Van Der Meeren O, Hardt K, Hezareh M, Roy-Ghanta S. Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9. PubMed 26873055 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.