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NCT00482781: PIA
Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants: A Randomized Multicenter Study
NA trial testing Infanrix in Prolonged Apnea in 191 participants. Completed in 1 September 2004.
Quick facts
| Lead sponsor | American SIDS Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 191 |
| Start date | 1 September 2000 |
| Estimated completion | 1 September 2004 |
| Sites | 10 locations across United States |
Drugs / interventions tested
Conditions studied
- Prolonged Apnea — all drugs for Prolonged Apnea →
- Prolonged Bradycardia — all drugs for Prolonged Bradycardia →
Sponsor
American SIDS Institute
Who can join
Adults 56 Days to 60 Days, any sex, with Prolonged Apnea or Prolonged Bradycardia. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Bedside recording of apnea and bradycardia with events verified by 2 independent scorers who were blinded to the study phase and immunization status of the subject.
Time frame: Six days (Three 48-hour periods).
Sponsor's own description
The purpose of this study is to examine the relationship between receipt of DTaP and the occurrence of prolonged episodes of apnea and bradycardia in preterm infants, while employing a random control study design and an objective assessment of cardiorespiratory events.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00482781
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Infanrix
Trials testing the same drug.
- NCT07160244 — BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies · Phase 3 · recruiting
- NCT02096263 — Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Month · Phase 3 · completed
- NCT01627561 — Safety and Immunogenicity of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine (GSK-580299) in Healthy Female Children 4-6 · Phase 3 · completed
- NCT00412854 — Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib. · Phase 3 · completed
- NCT00148941 — Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00482781 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by American SIDS Institute
- Last refreshed: 4 June 2007
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00482781.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing