Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00806195 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
A Phase 3 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 3
- Development phase
- 7,744
- Enrollment target
NCT00806195: Completed Phase 3 study, sponsored by Novartis.
NCT00806195 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 7,744 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (904% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00806195, a Phase 3 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 7,744 participants
- Enrollment target
Study Summary
The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants
Primary Outcome
To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
Interventions
- BIOLOGICAL MenACWY-CRM197
- BIOLOGICAL DTaP (Diptheria, Tetanus, Pertussis) Vaccine
- BIOLOGICAL Hib (Haemophilus influenza b) Vaccine
- BIOLOGICAL IPV (Inactivated Polio Vaccine) Vaccine
- BIOLOGICAL Pneumococcal conjugate Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,744 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT00806195 record still lists
NCT00806195 is an interventional study that assigns participants to a tested intervention. Its 7,744 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (904% higher).
The record links to 0 conditions, and to 5 interventions - of which MenACWY-CRM197 is the first listed.
NCT00806195 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00806195 about?
NCT00806195 is a clinical study titled "Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants". The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants
What is the current status of trial NCT00806195?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,744 participants. The study started on 2008-12. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00806195?
The interventions under investigation include: MenACWY-CRM197 (BIOLOGICAL), DTaP (Diptheria, Tetanus, Pertussis) Vaccine (BIOLOGICAL), Hib (Haemophilus influenza b) Vaccine (BIOLOGICAL), IPV (Inactivated Polio Vaccine) Vaccine (BIOLOGICAL), Pneumococcal conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00806195?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00806195's enrollment target sits among peer trials
7,744 33rd of 2000 higher than 1,968 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
- NCT06560398 · 7,649 participants · NA
Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)
- NCT03848312 · 7,600 participants · Phase 3
Preventing Alzheimer's With Cognitive Training
- NCT00439049 · 7,500 participants
Substance Abuse Pre-Treatment Screening Study
- NCT04809740 · 7,500 participants · NA
Evaluating the Implementation and Impact of Navigator-delivered ePRO System
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia