Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

Browse trials for

• Poliomyelitis 227

Keywords

• IPV
• PoliorixTM
• China

Poliomyelitis

227 studies on the registry are indexed under Poliomyelitis; 12 are open to participants now.

This study's enrollment of 957 is above the median of 456 across 203 interventional studies indexed under Poliomyelitis.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Study arms

• Experimental
  Group A

  Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.

  Biological: PoliorixTM · Biological: Infanrix+Hib

• Active comparator
  Group B

  Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.

  Biological: Infanrix+Hib

Interventions

• BiologicalPoliorixTM

  Single dose, intramuscular administration

• BiologicalInfanrix+Hib

  Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Primary outcomes

1. Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value

   A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.

   Time frame: One month after Poliorix™ booster vaccination.

2. Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value

   A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.

   Time frame: Before booster vaccination.

3. Antibody Titers Against Poliovirus Type 1, 2 and 3

   Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.

   Time frame: One month after Poliorix™ booster vaccination.

4. Antibody Titers Against Poliovirus Type 1, 2 and 3.

   Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.

   Time frame: Before booster vaccination.

Secondary outcomes

1. Number of Subjects With Any and Grade 3 Solicited Local Symptoms

   Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects in the Poliorix Group only.

   Time frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.

2. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

   Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature ≥ 37.1 degrees Celsius (°C)\]. Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 fever = fever (axillary temperature) \>39.0°C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as causally related to the vaccination. This outcome measure concerns subjects in the Poliorix Group only.

   Time frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.

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

   An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.

   Time frame: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.

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

   Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

   Time frame: During the entire study period (Day 0 to Month 1).

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 ↗

Related links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. ↗

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.