Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01000974 · ClinicalTrials.gov registry record · Phase 3
Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,003
- Enrollment target
NCT01000974: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01000974 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,003 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (419% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01000974, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,003 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.
Primary Outcome
Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL).
Interventions
- BIOLOGICAL Prevnar 13™
- BIOLOGICAL Pentacel™
- BIOLOGICAL GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)
- BIOLOGICAL ActHIB™
- BIOLOGICAL Pediarix™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,003 participants |
| Start Date | 2010-06-18 |
| Est. Completion | 2013-07-17 |
| Phase | Phase 3 |
What the finished NCT01000974 record still lists
NCT01000974 is an interventional study that assigns participants to a tested intervention. Its 4,003 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (419% higher).
The record links to 0 conditions, and to 5 interventions - of which Prevnar 13™ is the first listed.
NCT01000974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01000974 about?
NCT01000974 is a clinical study titled "Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants". The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the ...
What is the current status of trial NCT01000974?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,003 participants. The study started on 2010-06-18. Estimated completion is 2013-07-17.
What interventions are being tested in trial NCT01000974?
The interventions under investigation include: Prevnar 13™ (BIOLOGICAL), Pentacel™ (BIOLOGICAL), GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108) (BIOLOGICAL), ActHIB™ (BIOLOGICAL), Pediarix™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT01000974?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01000974's enrollment target sits among peer trials
4,003 61st of 2000 higher than 1,940 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00227253 · 4,000 participants
Chromosome 18 Clinical Research Center
- NCT00811148 · 4,000 participants
Florida Center for Brain Tumor Research
- NCT00897117 · 4,000 participants
Collecting and Analyzing Tissue Samples From Patients Undergoing Surgery for Non-Small Cell Lung Cancer
- NCT00899301 · 4,000 participants
Collecting and Storing Tissue Samples From Women With or Without Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI